What is new in Oncology? Learn everything about the latest advancements in oncology on the MediPR (MediPaper) website. We have the latest news for different oncologic diseases, including immunotherapy, endocrine therapy, targeted therapy, and chemotherapy.

ASCO 2019 lung cancer NSCLC ASCO19 SCLC mesothelioma KEYNOTE-189 KEYNOTE-001 IMpower150 MYSTIC LCMC3 Lung-MAP S1400G S1400I Flaura CALGB 30901 DETERRED COMPASS

ASCO 2019 Lung Cancer: 36 Oral Presentations of the ASCO19 lung cancer track summarised

Non-small cell lung cancer (NSCLC) was a key feature of the American Society of Clinical Oncology (ASCO) 2019 annual meeting. This year, exciting results with neoadjuvant immunotherapy (I-O) from the LCMC3, NEOSTAR, and GECP16/03_NADIM studies as well as combinations of I-O  and PARP-inhibitors with chemoradiation therapy, and more. A summary of 36 oral presentations on NSCLC, SCLC, and Mesothelioma.

paclitaxel, cobimetinib, Cotellic, MEK, Exelixis, atezolizumab, Tecentriq, nab-paclitaxel pembrolizumab, Keytruda, Merck, MSD, eribulin mesylate, Halaven, pertuzumab, trastuzumab, Herceptin, Perjeta, docetaxel, Taxotere, Sanofi, trastuzumab-dkst, Ogivri, Mylan, Biocon, margetuximab, MacroGenics, capecitabine, Xeloda, Genentech, gemcitabine, Gemzar, vinolrebine, pyrotinib, Jiangsu HengRui Medicine, neratinib, Nerlynx, Puma, lapatinib, Tykerb, carboplatin, T-DM1, ado-trastuzumab emtansine, Kadcyla doxorubicin, cisplatin, olaparib, Lynparza, cyclophosphamide, epirubicin, Ellence, Pharmorubicin, letrozole, Femara, Novartis, AI, NSAI, capivasertib, capivasertib, AZD5363, AKT, hormonal therapy, endocrine therapy, CDK4/6, RAD001, mTOR, fulvestrant, Faslodex, abemaciclib, Verzenio, Eli Lilly, ribociclib, Kisqali, goserilin, Zoladex, AstraZeneca, everolimus, Afinitor, exemestane, Aromasin, Pfizer, palbociclib, Ibrance, #ASCO2019, AKT1, AZ, BRCA, chemotherapy, CNS metastases, ER-positive, ESR1, GnRH, HER2-negative, HER2-positive, HR-positive, LABC, neoadjuvant, OfS, PARP, PARPi, pCR, PD-L1, postmenopausal, PR-positive, premenopausal, RB1, TAC, taxane, TNBC, trastuzumab, triptorelin

ASCO 2019 Breast Cancer: The ASCO19 breast cancer track summarised

Breast cancer: a front-runner when it comes to the development of novel therapeutic strategies. With the advent of newer targeted- and immunotherapies, oncologists have an increment of options to offer their patients. The American Society of Clinical Oncology’s (ASCO) 2019 Breast Cancer track offered an extensive look at the latest advancements and updates from on-going trials covering the various subtypes of breast cancer.

Venetoclax FDA approved for CLL and SLL

On 15 May 2019, the FDA approved venetoclax (Venclexta®, AbbVie/Genentech) for the treatment of adult chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) patients.

FDA approves avelumab plus axitinib for renal cell carcinoma

On 14 May 2019, the FDA approved the combination of avelumab (Bavencio®, Merck KGaA/Pfizer) plus axitinib (Inlyta®, Pfizer) for the first-line treatment of advanced renal cell carcinoma (RCC) patients.

Ramucirumab FDA approved for hepatocellular carcinoma

On 10 May 2019, the FDA approved single agent ramucirumab (Cyramza®, Eli Lilly) for the treatment of hepatocellular carcinoma (HCC) patients previously treated with sorafenib and who have an alpha-fetoproteintein (AFP) of ≥ 400 ng/mL.

T-DM1 FDA approved for early breast cancer

On the 3rd of May 2019, the FDA approved ado-trastuzumab emtansine (Kadcyla® [T-DM1], Genentech/Roche) as adjuvant therapy for human epidermal growth factor receptor (HER2)-positive early breast cancer (EBC) patients with residual invasive disease after neoadjuvant treatment with a taxane and trastuzumab.

Ivosidenib FDA-approved as first-line treatment for AML patients with IDH1 mutation

On the 2nd of May 2 2019, the FDA approved ivosidenib (Tibsovo®, Agios) as treatment for newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old and AML patients with comorbidities precluding intensive induction chemotherapy. Patients should harbour a susceptible IDH1 mutation, as per the FDA-approved Abbott RealTime™ IDH1 Assay, to be legible for ivosidenib treatment.

Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?

Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?

UPPSALA, Sweden, April 24, 2019 /PRNewswire/ — Researchers of the Erasmus University Medical Center in Rotterdam − the Netherlands, consider that the synthetic and fully resorbable TIGR® Matrix surgical mesh (Novus Scientific AB, Uppsala − Sweden) may reduce frequent risks related to the surgical repair of Sportsman’s hernia.

Pembrolizumab plus axitinib FDA approved for the first-line treatment of advanced renal cell carcinoma patients

On 19 April 2019, the FDA approved the programmed death 1 (PD-1) inhibitor pembrolizumab (KEYTRUDA®, Merck) plus axitinib – a selective and potent receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 – as a first-line treatment for advanced renal cell carcinoma (RCC) patients.

KEYNOTE-158 pembrolizumab in previously treated advanced cervical cancer

KEYNOTE-158: pembrolizumab in previously treated advanced cervical cancer

Immunotherapy with programmed death 1 (PD-1) antibody pembrolizumab led to an objective response rate (ORR) of 14.6% in previously treated advanced cervical cancer patients with PD-L1–positive disease, as reported by Chung et al. on behalf of the KEYNOTE-158 investigators in the Journal of Clinical Oncology.

Atezolizumab with or without cobimetinib vs regorafenib for previously treated metastatic colorectal cancer IMblaze370

Atezolizumab +/- cobimetinib vs regorafenib for previously treated metastatic colorectal cancer (IMblaze370)

Combining programmed death 1 ligand (PD-L1) inhibitor atezolizumab with MEK-inhibitor cobimetinib in patients with previously treated metastatic colorectal cancer (mCRC) does not improve the overall survival (OS) when compared to regorafenib, as was reported by the investigators of the IMblaze370 (NCT02788279) trial in the Lancet Oncology.

Palbociclib approved for the treatment of male breast cancer 

On 4 April 2019, the US FDA approved palbociclib (Ibrance®, Pfizer) plus aromatase inhibitor or fulvestrant for the treatment of male patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

Erdafitinib FDA approved for the treatment of metastatic urothelial carcinoma

On 12 April 2019, the FDA granted accelerated approval to erdafitinib (Balversa®, Janssen) for the treatment of locally advanced or metastatic urothelial cell carcinoma (mUCC) progressed during or following a platinum-containing regimen, including progression within 12 months of (neo)adjuvant platinum-based chemotherapy, and whose tumours harbour susceptible fibroblast growth factor receptor (FGFR) 3 or FGFR2 genetic alterations as determined by the FDA approved companion diagnostic (CDx), the therascreen® FGFR RGQ RT-PCR Kit by Qiagen.

Atezolizumab FDA approved for extensive-stage small cell lung cancer (SCLC)

On 18 March 2019, the FDA approved atezolizumab (Tecentriq®, Genentech) plus carboplatin and etoposide as front-line treatment of adult extensive-stage small cell lung cancer (ES-SCLC) patients.

Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer

On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).

U.S. FDA approved immunecheckpoint inhibitors U.S. FDA approved immunotherapies for cancer U.S. FDA approved immunotherapies for cancer

US FDA approved immune-checkpoint inhibitors updated 09-Mar-2019

Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.

Immunoncology I-O drugs and immunotherapy for renal cancer RCC

Combinations: upcoming treatment strategies in metastatic renal cell carcinoma

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Trifluridine/tipiracil combination FDA approved for metastatic gastric or GEJ adenocarcinoma

On 22 February 2019, the FDA approved the fixed combination tablets of the nucleoside metabolic inhibitor trifluridine plus the thymidine phosphorylase inhibitor tipiracil (Lonsurf®, Taiho Pharmaceutical) for the treatment of adult metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients pretreated with two or more prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan plus (when appropriate) HER2/neu-targeted therapy.

Pembrolizumab FDA approved for adjuvant treatment of melanoma

On 15 February 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of melanoma patients with lymph node involvement following complete resection.

Trastuzumab-biosimilar Ontruzant® FDA approved in several indications

On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.

Cabozantinib FDA approved in HCC patients failing sorafenib

On 14 January 2019, the FDA approved cabozantinib (Cabometyx®, Exelixis) for hepatocellular carcinoma (HCC) patients previously treated with sorafenib.

Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

The synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala − Sweden) might be an interesting candidate for the prevention of complications frequently observed with permanent mesh placement, according to Professor Johan Lange of the Erasmus University in Rotterdam − the Netherlands.

Keytruda® FDA approved for recurrent and metastatic Merkel cell carcinoma

On 19 December 2018, pembrolizumab (Keytruda®, Merck) received accelerated approval by the FDA for the treatment of recurrent locally advanced or metastatic (R/M) Merkel cell carcinoma (MCC) in adult and paediatric patients.

Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients

On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).

Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)

On 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer

On 19 December 2018, the FDA approved olaparib (Lynparza®, AstraZeneca) as a maintenance treatment for adult advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients who achieving a complete or partial response to first-line platinum-based chemotherapy and who have deleterious germline or somatic BRCA-mutatations (gBRCAm or sBRCAm) by an FDA-aproved test or who are suspected to have deleterious BRCA-mutatations (BRCAm). 

Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer

On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.

Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC

On 6 December 2018, the FDA approved atezolizumab (Tecentriq®, Roche/Genentech) plus bevacizumab and chemotherapy with paclitaxel and carboplatin for the frontline treatment of metastatic non-squamous non-small cell lung cancer (NSq NSCLC) patients not harbouring any EGFR or ALK genomic tumour aberrations.

MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab

MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab

On the first day of the 2018 American Society of Hematology (ASH) Annual Meeting, an additional year of follow-up data from the practice-changing MURANO study were presented to the audience by Professor John F. Seymour. In the trial’s setting of relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL), the non-chemo-containing regimen venetoclax (Venclexta®, AbbVie/Roche) plus rituximab was associated with maintained superior progression-free survival (PFS) and overall survival (OS) over standard-of-care chemoimmunotherapy with bendamustine plus rituximab. At the same time, a durable post-treatment disease control is also attainable with the fixed-duration chemo-free regimen.

TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

Onlay mesh placement of the synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala — Sweden) for the prevention of incisional hernia in septic patients undergoing emergency laparoscopy showed encouraging efficacy and safety in a small retrospective study, as presented during the XXVIII Waterford Surgical October Club Meeting.

Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations

On 28 November 2018, the FDA approved gilteritinib (Xospata® [ASP2215], Astellas) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML) harbouring FLT3 mutations as confirmed by an FDA-approved companion diagnostic test (CDx).

TKR inhibitor larotrectinib (Vitrakvi®) FDA approved for cancers with NTRK gene fusion

On 26 November 2018, the FDA granted accelerated approval to the first-in-class tropomyosin receptor-kinase (TRK) inhibitor larotrectinib (Vitrakvi®, Loxo Oncology/Bayer) for the treatment of adult and paediatric patients with solid tumours that are metastatic or not amenable to surgery, harbour the neurotrophic receptor tyrosine kinase (NTRK) gene fusion in the absence of known acquired resistance mutations, and whose cancer progressed following treatment or for whom are no satisfactory other treatment options available.

FDA Approves Truxima as Biosimilar to Rituxan

Venetoclax plus azacitidine, decitabine, or low-dose cytarabine FDA approved in elderly AML patients

On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in patients with comorbidities precluding intensive induction chemotherapy.

Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients

On 21 November 2018, the FDA approved glasdegib (Daurismo®, Pfizer) in combination with low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in patients of 75 years or older and in patients with comorbidities contraindicating intensive induction chemotherapy.

Robert Lewandowski Y90 TARE TheraSphere The Emerging Role of Yttrium90 in Primary and Metastatic Liver Cancer hepatocellular carcinoma hcc

The Emerging Role of Yttrium-90 in Primary and Metastatic Liver Cancer

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Emapalumab FDA approved in adult and paediatric patients with primary hemophagocytic lymphohistiocytosis

On 20 November 2018, the FDA approved the interferon-γ neutralising monoclonal antibody emapalumab (Gamifant®, Novimmune) for the treatment of adult and paediatric (newborn and older) patients with refractory, recurrent, or progressive primary haemophagocytic lymphohistiocytosis (HLH) or in patients intolerant to conventional HLH therapy.

Brentuximab vedotin (Adcetris®) plus chemotherapy approved for several CD30 expressing lymphomas

On 16 November, 2018, the FDA approved brentuximab vedotin (Adcetris®, Seattle Genetics) in combination with chemotherapy for the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS).

Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

UPPSALA, Sweden, Nov. 21, 2018 /PRNewswire/ — Using the synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala — Sweden) improves the outcome in breast cancer patients undergoing immediate reconstruction, as published in the Journal of Plastic Surgery and Hand Surgery.

Pembrolizumab FDA approved in hepatocellular carcinoma patients pretreated with sorafenib

On 9 November 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.

Lorlatinib FDA approved for metastatic ALK-positive NSCLC

On November 2nd 2018, lorlatinib (LORBRENA®, Pfizer) received accelerated approval by the FDA for the second- and third-line treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC). Third-line patients should have had progression on crizotinib and another ALK-inhibitor for metastatic disease, and second-line patients should have had progression on either alectinib or ceritinib in the first-line for metastatic disease.

ESMO 2018 HCC ESMO18 Liver Cancer ESMO2018 hepatocellular carcinoma hepatobiliary cholangiocarcinoma BTC

ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised

Whereas this year’s American Society of Clinical Oncology Annual Meeting (ASCO 2018) boasted two Phase III studies and four Phase II studies with notable results in hepatocellular carcinoma (HCC), the trend did not continue to the European Society for Medical Oncology Conference (ESMO 2018), held in Münich, Germany between October 19-23, 2018. The focus for this years ESMO was mostly on biliary-tract cancers (BTC). Welcome to the hepatobiliary track of ESMO 2018.

Pembrolizumab plus chemotherapy approved for metastatic squamous NSCLC

On October 30th 2018, the FDA approved the use of programmed death 1 (PD-1) inhibitor pembrolizumab (Keytruda®, Merck) in combination with carboplatin plus paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

Dr Joanne Chiu HKU management irAE hepatitis manage immune-mediated hepatitis immunotherapy I-O immunooncology immune-induced hepatitis

Management of Immune-Mediated Hepatitis: a Case Report

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PARPi talazoparib FDA approved for deleterious gBRCAm HER2‑negative breast cancer

On October 16, 2018, the FDA approved PARP-inhibitor talazoparib (Talzenna®, Pfizer) for use in patients with deleterious or suspected deleterious germline BRCA-mutated locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Patients should be selected for the PARP inhibitor (PARPi)-treatment using an FDA-approved companion diagnostic (CDx) for talazoparib.

innovent biologics anti-pd1 sintilimab plus biosimilar bevacizumab receive ind status by china nmpa

Anti-PD1 sintilimab plus biosimilar bevacizumab receive IND-status by China NMPA

SUZHOU, China, Oct. 14, 2018 /PRNewswire/ — The combination therapy of novel programmed death 1 (PD-1) antibody IBI308 (sintilimab, Innovent Biologics) with biosimilar bevacizumab antibody IBI305 (Innovent Biologics) has received the investigational new drug (IND) application for clinical development approval by the National Medical Products Administration (NMPA, formerly known as CFDA) in China.

IMpower133 first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer

IMpower133: first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer

Atezolizumab (Tecentriq®, Roche/Genentech) plus standard chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer (SCLC) was associated with a significantly longer overall survival (OS) and progression-free survival (PFS) when compared with chemotherapy alone.

Pembrolizumab plus chemotherapy effective in squamous NSCLC

Pembrolizumab plus chemotherapy effective in squamous NSCLC

Pembrolizumab (Keytruda®, Merck) in combination with chemotherapy was associated with longer overall survival (OS) and progression-free survival (PFS) when compared to placebo plus chemotherapy in patients with untreated metastatic squamous cell non-small cell lung cancer (NSCLC).

Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer

Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer

Adding ipilimumab (IPI [Yervoy®, Bristol-Myers Squibb]) to nivolumab (NIVO [Opdivo®, Bristol-Myers Squibb]) induction followed by maintenance with single-agent NIVO had a superior objective tumour response rate and progression-free survival (PFS) when compared to NIVO alone in patients with persistent or recurrent epithelial ovarian cancer.

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

Brigatinib (Alunbrig®, Ariad) significantly prolongs the progression-free survival (PFS) in anaplastic lymphoma kinase (ALK) inhibitor-naïve patients with ALK-rearranged non-small cell lung cancer (NSCLC) when compared to crizotinib, as resulted from the ALTA-1L study.

CAR-T axicabtagene ciloleucel granted Orphan Drug Designation for B-Cell Lymphoma by the Japan MHLW

CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW

TOKYO and BASKING RIDGE, N.J., October 3, 2018 /PRNewswire/ — The Japan Ministry of Health, Labour and Welfare (MHLW) granted the Orphan Drug designation to axicabtagene ciloleucel (KTE-C19, Daiichi Sankyo) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL),  high-grade B-cell lymphoma (HGBL), and transformed follicular lymphoma (TFL), which are all aggressive forms of non-Hodgkin lymphoma (NHL). 

PD-1 mAB cemiplimab FDA approved for locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC)

On September 28, 2018, the FDA approved programmed death 1 (PD-1) immune-checkpoint inhibitor cemiplimab-rwlc (Libtayo®, Regeneron) for use in patients with metastatic cutaneous squamous cell carcinoma (CSCC) and patients with locally advanced CSCC unamenable for curative surgery or curative radiation.

JAVELIN Lung 200 avelumab vs docetaxel in patients with pretreated advanced non-small cell lung cancer NSCLC

JAVELIN Lung 200: avelumab vs docetaxel for pretreated NSCLC

Avelumab (Bavencio®, Merck KGaA) does not improve the overall survival (OS) in non-small cell lung cancer (NSCLC) patients previously treated with platinum-doublet chemotherapy, as resulted from the JAVELIN Lung 200 study (NCT02395172). The safety profile favoured avelumab over docetaxel.

Dacomitinib FDA approved for the first-line treatment of metastatic EGFR-mutated NSCLC

On September 27, 2018, the FDA approved dacomitinib (Vizimpro®, Pfizer) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R mutations as confirmed by an FDA-approved test.

Duvelisib FDA approved for adult patients with R/R CLL or SLL

On September 24, 2018, the US FDA granted regular approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior therapies.

Duvelisib FDA approved for adult patients with R/R follicular lymphoma

On September 24, 2018, the US FDA granted accelerated approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies.

Front-line atezolizumab plus chemotherapy improves PFS in NSCLC

Frontline atezolizumab plus chemotherapy improves PFS in NSCLC

An interim analysis of the Phase III IMpower132 study showed that atezolizumab (Tecentriq®, Roche/Genentech) plus platinum-based chemotherapy (cisplatin or carboplatin) with pemetrexed improves the median progression-free survival (PFS) in treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). The median PFS for atezolizumab plus pemetrexed and a platinum salt was 7.6 months vs 5.2 months with chemotherapy alone (HR=0.60, 95% CI: 0.49-0.72; p<0.0001).

First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC

First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC

First-line osimertinib was associated with a clinically meaningful progression-free survival (PFS) improvement when compared to a standard-of-care (SOC) epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in a sub-analysis of Asian patients who participated in the FLAURA trial (NCT02296125).

Early breast cancer treatment in China remains conservative

Early breast cancer treatment in China remains conservative

Breast-conserving surgery is uncommon in China, and despite routinely performing SLNB the uptake of the ACOSOG Z0011 study recommendation to treat selected sentinel node-positive patients with whole breast irradiation and adjuvant systemic therapy instead of ALND remains low at only 17% of Chinese centres. These were the key findings of a national survey among 520 Chinese hospitals.

ImmunoOncology: Dr Oscar Chan on the treatment of irAE rash

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Prof Stefan Kasper on I-O in EXTREME-ineligible Head and Neck Cancer I-O in SCCHN with focus on EXTREME-ineligible Patients and the future directions of combination immunotherapy

Prof Stefan Kasper on I-O in EXTREME-ineligible SCCHN

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Camrelizumab anti-PD-1 with or without Chemotherapy for NPC

Camrelizumab anti-PD-1 with or without chemotherapy for NPC

Camrelizumab (SHR-1210, Hengrui Medicine), a novel programmed death 1 (PD-1) inhibitor, plus gemcitabine and cisplatin showed a manageable toxicity profile with promising, preliminary anti-tumour activity in treatment-naïve Chinese nasopharyngeal carcinoma (NPC) patients. Larger, randomised controlled trials may provide further insight into the role of anti-PD1 for NPC, wrote the authors in the Lancet Oncology.

Moxetumomab pasudotox-tdfk FDA approved for hairy cell leukaemia

On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti®, AstraZeneca) for adult patients with relapsed or refractory (R/R) hairy cell leukaemia (HCL) who had received at minimum two prior systemic therapies, of which one a purine nucleoside analogue (PNA).

I-O in Special Populations: the Treatment of Immunotherapy-Induced Pneumonitis

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Venetoclax FDA label updated to include Minimal Residual Disease negativity data

On the 11th of September 2018, the FDA updated the label of venetoclax tablets (VENCLEXTA®, Abbvie) in combination with rituximab (MabThera®, Roche) to include information about pre-treated patients with chronic lymphocytic leukemia (CLL) in the Phase III MURANO trial who had achieved Minimal Residual Disease (MRD)-negativity.

Quizartinib Receives Orphan Drug Designation for FLT3-Mutated AML in Japan

Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan

TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018  — The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.

Capmatinib plus gefitinib promising in MET-dysregulated NSCLC

The combination capmatinib (INC280, Novartis) plus gefitinib (Iressa®, AstraZeneca) showed promising, early phase efficacy in patients with mesenchymal-epithelial transition factor (MET)-dysregulated and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

CAR-TCR Summit 2018: Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer

CARsgen Therapeutics, a Shanghai-based clinical-stage immune-oncology company committed to developing Chimeric Antigen Receptor T (CAR-T) cell therapies for cancer, presented preliminary data of their first-in-class CAR-Claudin18.2 T-cell clinical trial in pancreatic and gastric cancer patients during the 2018 CAR-TCR Summit in Boston.

DRIVER connects cancer patients in China and the United States to the best care

SAN FRANCISCO and SHANGHAI, Sept. 6, 2018/PRNewswire/ — Today, Driver, a global technology platform that connects cancer patients to the best treatments, launches in the United States and China. Driver’s platform enables any patient, anywhere in the world, to access treatment options across an unprecedented network of cancer centres without leaving home.

Blood-based TMB-assay predicts response to atezolizumab in NSCLC patients

Plasma TMB predicts response to atezolizumab in NSCLC patients

A high tumour mutational burden in the plasma (bTMB) is a clinically actionable biomarker for atezolizumab (Tencentriq®, Roche) treatment in patients who failed 1st-line platinum-based therapy for advanced non-small cell lung cancer (NSCLC).

First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation

Biosceptre has announced the initiation of its Phase 1 clinical study with the peptide vaccine BIL06v. BIL06v is a peptide-protein conjugate that recruits the patient’s immune system to make antibodies specifically targeted at nfP2X7-expressing cancer cells resulting in tumour cell death.

Pembrolizumab and atezolizumab USPIs updated by FDA

On the 16th of August, 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 levels in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.

Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)

On the 16th of August 2018, the FDA granted accelerated approval to nivolumab (Opdivo®, Bristol-Myers Squibb) for use in patients with metastatic small cell lung cancer (SCLC) who progressed after two lines of therapy, including one line of platinum-based chemotherapy.

Pembrolizumab plus pemetrexed-platinum approved for use in the 1st-line treatment of metastatic non-squamous NSCLC

Pembrolizumab plus pemetrexed-platinum FDA approved for first-line treatment of metastatic non-squamous NSCLC

On 20th of August 2018, the FDA granted regular approval for pembrolizumab (Keytruda®, Merck) plus pemetrexed and a platinum salt in the first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSCLC), not harbouring any EGFR or ALK genomic tumour aberrations.

Talazoparib in advanced breast cancer patients with a germline BRCA1:2 mutation

Talazoparib in advanced breast cancer patients with a germline BRCA1/2 mutation

Single-agent PARP-inhibition with talazoparib is associated with an improved progression-free survival (PFS) and better patient-reported outcomes (PRO) when compared to chemotherapy alone in patients with advanced breast cancer (ABC) and a germline BRCA1/2 mutation, as reported by the investigators of the Phase III EMBRACA study (NCT01945775) in the New England Journal of Medicine.

CheckMate 032 Nivolumab ipilimumab metastatic esophagogastric cancer

CheckMate 032: Nivolumab +/- ipilimumab for metastatic esophagogastric cancer

Immunotherapy with either nivolumab (Opdivo®, Bristol-Myers Squibb) alone or the combination nivolumab plus ipilimumab (Yervoy®, Bristol-Myers Squibb) in patients with chemotherapy-refractory esophagogastric cancer leads to durable responses and encouraging long-term overall survival with a manageable safety profile, concluded the investigators of the CheckMate 032 study. 

Pembrolizumab plus pemetrexed-platinum approved for use in the 1st-line treatment of metastatic non-squamous NSCLC

Lenvatinib FDA approved for 1st-line treatment of HCC

On August 16, 2018 the FDA approved lenvatinib (Lenvima®, Eisai) for the first-line treatment of hepatocellular carcinoma (HCC) patients not amenable for curative surgery.

Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China

HONG KONG, CHINA – 13 August 2018 – Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), announced that its innovative in-house developed oncology drug pirotinib has commenced into Phase II Clinical testing in China following the completion of a Phase I clinical trial in three renowned cancer research centres in the United States. 

FDA approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. More Information.  July 31, 2018.

FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL

On the 8th of August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin), a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, for use in adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).

FDA approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. More Information.  July 31, 2018.

Lusutrombopag FDA approved for thrombocytopenia in adult chronic liver disease patients

On the 31st of July 2018, the FDA approved lusutrombopag (Mulpleta®, Shionogi) for thrombocytopenia in adult chronic liver disease (CLD) patients scheduled for an invasive medical or dental procedure.

Iobenguane I-131 FDA approved for rare adrenal neuroendocrine tumours

On July 30, 2018, the FDA approved iobenguane I-131 (Azedra®, Progenics Pharmaceuticals), a radioactive therapeutic agent, for the treatment of adult and paediatric patients ≥12 years with iobenguane scan positive, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) not amenable to surgery and indicated for systemic therapy.

Osimertinib in patients with T790M-positive advanced non-small cell lung cancer and brain metastases (AURA3)

Osimertinib is active in the second-line treatment of patients with T790M-positive advanced non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases, as reported by the investigators of the Phase III AURA3 study.

Anti-PD1 with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma

Anti-PD1 with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma

Programmed death 1 (PD-1) inhibition with the novel human anti-PD1 monoclonal antibody cemiplimab (REGN2810, Regeneron and Sanofi) in patients with locally advanced or metastatic cutaneous squamous-cell carcinoma (CSCC) resulted in a response in approximately half of the patients.

Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia

On July 20, 2018, the US FDA approved ivosidenib (Tibsovo©, Agios Pharmaceuticals) for use in adult patients with relapsed or refractory acute myeloid leukaemia (AML) harbouring a susceptible IDH1 mutation as detected by an FDA-approved companion diagnostic (CDx) test, the Abbott RealTime IDH1 Assay.

FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information.  July 13, 2018

Filgrastim-aafi FDA approved as Filgrastim Biosimilar

On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.

Ribociclib FDA label updated to include pre- and perimenopausal women

On July 18, 2018, the US FDA expanded the ribociclib (Kysqali©, Novartis)  approval. Ribociclib plus an aromatase inhibitor as initial endocrine-based therapy is no longer limited to postmenopausal HR-positive, HER2-negative advanced or metastatic breast cancer patients alone and now includes pre- and perimenopausal women. Furthermore, the FDA has added the combination ribociclib plus fulvestrant as initial endocrine-based therapy for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information.  July 13, 2018

Enzalutamide FDA approved for castration-resistant prostate cancer (CRPC)

On July 13, the FDA approved enzalutamide (Xtandi©, Astellas), for use in patients with castration-resistant prostate cancer (CRPC).

EBV, MSI, and CPS predict pembrolizumab outcome in gastric cancer

Metastatic gastric cancer (mGC) patients with microsatellite instability-high (MSI-H) or Epstein-Barr virus (EBV)-positive tumours, or those with a positive (≥1%) combined positive score (CPS) respond best to pembrolizumab PD-1 immunotherapy.

Ipilimumab plus nivolumab FDA approved for MSI-H and dMMR pre-treated mCRC

On July 10th, the FDA granted accelerated approval to ipilimumab (Yervoy©, Bristol-Myers Squibb) for use in combination with nivolumab (Opdivo©) for the treatment of adult and paediatric patients ≥12 years of age with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Combination encorafenib plus binimetinib for unresectable/metastatic BRAF V600E or V600K-positive melanoma FDA approved

On June 27th, the FDA approved Array Biomarpharma’s combination encorafenib (BRAFTOVI®) plus binimetinib (and MEKTOVI®) for patients with unresectable or metastatic melanoma harbouring a BRAF V600E or V600K mutation detected by an FDA-approved test.

ASCO 2018 NSCLC: The ASCO18 Lung Cancer Track Summarised

Non-small cell lung cancer (NSCLC): a key feature of the American Society of Clinical Oncology (ASCO) 2018 annual meeting. This year, encouraging results with single-agent immunotherapy (I-O) and combinations of I-O with chemotherapy (CTx), including the CheckMate 227 with nivolumab (NIVO), IMpower131 and IMpower150 studies with atezolizumab (ATEZO), and KEYNOTE-042 and KEYNOTE-407 studies with pembrolizumab (PEMBRO). Furthermore, important Asian data on treatments for epidermal growth-factor recptor (EGFR) mutation-positive (mu+) NSCLC (ARCHER 1050, NEJ009, NEJ026, and JO25567).

FDA  has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.  More Information.  June 19, 2018

FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma

On June 19, the FDA limited the use of atezolizumab and pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-containing therapy.

ASCO 2018 Breast Cancer: The ASCO18 breast cancer track summarised

Breast cancer: a front-runner when it comes to the development of novel therapeutic strategies. With the advent of newer targeted- and immunotherapies, oncologists have an increment of options to offer their patients. The American Society of Clinical Oncology’s (ASCO) 2018 Breast Cancer track offered an extensive look at the latest advancements and updates from on-going trials covering the various subtypes of breast cancer.

Bevacizumab in combination with carboplatin and paclitaxel FDA approved for several types of gynaecological cancers

 

FDA approved pembrolizumab for 3rd-line PMBCL in adult and pediatric patients

 

  • On June 13, 2018, the US FDA has granted accelerated approval to pembrolizumab (KeytrudaⓇ, Merck & Co. Inc.) for the treatment of adult and pediatric patients with primary mediastinal large B-cell lymphoma (PMBCL), relapsed after two or more prior lines of prior therapy.

FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1 

 

ASCO 2018 HCC: The ASCO18 hepatocellular cancer track summarised

This year’s American Society of Clinical Oncology (ASCO) annual meeting includes two Phase III studies in the second-line treatment of the disease. Moreover, data with several immune-checkpoint inhibitors were presented, including the KEYNOTE-224 with pembrolizumab. Welcome to the summary of the ASCO 2018 HCC track.

FDA approves venetoclax in 2nd-line for patients with CLL or SLL

 

FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy

 

AACR 2018: first-line atezolizumab, bevacizumab plus chemotherapy active in non-squamous NSCLC

First-line atezolizumab plus bevacizumab, carboplatin and paclitaxel improves PFS in patients with non-squamous NSCLC. Two presentations on the IMPower150 study by Martin Reck (ELCC 2018) and Mark Socinski (AACR 2018) discussed the frontline addition of atezolizumab to bevacizumab and chemotherapy in different lung cancer subgroups (NCT02366143).