ImmunoOncology (I-O) is a fast developing field in which drugs stimulate the patient’s immune system to fight cancer. I-O include immune-checkpoint inhibitors, vaccines, and DAR-T, CAR-T cell & BiTE immunotherapies. Read our I-O blog and learn more about this fast-evolving field of medicine.
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
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 +/- 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.
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).
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.
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.
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).
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
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 (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
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.
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 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.
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).
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.
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.
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.
© FDAPembrolizumab 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 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.
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.
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.
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.
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 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.
FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1
- On June 12, 2018 the FDA approved pembrolizumab (KeytrudaⓇ, Merck & Co. Inc.) for patients with chemotherapy-refractory recurrent or metastatic (r/m) cervical cancer and with a combined positive score (CPS)≥1 PD-L1 level expression.
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.
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).
US FDA approved CAR-T cell and BiTE immunotherapy – Updated 2-May-2018
The two CAR-T cell immunotherapies axicabtagene ciloleucel (Yescarta®) and tisagenlecleucel (Kymriah®) and the BiTE blinatumomab (Blincyto®) have in common that they target CD19 on the cancer cells. Do you know all the US FDA approved CAR-T and BiTE immunotherapies?
Nivolumab-Ipilimumab Combination: A New Option for TMB-High NSCLC (CheckMate 227)
AACR 2018: First-line nivolumab–ipilimumab in TMB-high NSCLC with was associated with a more than tripled 1-year progression-free survival (PFS) rate compared to platinum-based chemotherapy in the Phase III CheckMate 227 trial (NCT02477826).
Frontline Combination of Pembrolizumab and Chemotherapy: A New Standard of Care for Non-squamous NSCLC
AACR 2018: Frontline pembrolizumab plus chemotherapy in NSCLC reduces the risk of death by more than 50%. The Phase III KEYNOTE-189 trial combined pembrolizumab (Keytruda®) plus standard of care platinum-based chemotherapy in non-squamous non–small cell lung cancer (NSCLC) without EGFR or ALK genetic aberrations (NCT0278680)
Pembrolizumab effective in frontline NSCLC with low PD-L1 expression
Pembrolizumab (Keytruda®) as single-agent immunotherapy in the frontline setting of any histology NSCLC with a PD-L1 expression ≥1% was associated with improved overall survival (OS) when compared to platinum-doublet chemotherapy in the KEYNOTE-042.
Nivolumab for NPC: immunotherapy active in nasopharyngeal carcinoma (NCI-9742)
Nivolumab (OpdivoⓇ) immunotherapy is active in nasopharyngeal carcinoma (NPC). A study published in JCO by Brigette Ma (CUHK) and a team of researchers from Hong Kong, Singapore, and the US showed promising results with nivolumab in NPC. Read more about immunotherapy in NPC.
©FDA granted accelerated approval to blinatumomab for the treatment of adult and paediatric patients with B-cell precursor ALL in first or second complete remission with MRD ≥0.1%
- FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and paediatric patients with B-cell precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. More Information.
Making sense of 1st-line immunotherapy in non-small cell lung cancer (NSCLC)
The expansion of therapeutic options with immunotherapies will reflect a dramatic change in the guidelines for lung cancer, where immunotherapies mostly compete with the use of chemotherapeutic agents. A brief communication on immunotherapies for NSCLC.
Pembrolizumab approved for advanced gastric cancer
On September 22, 2017, the FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for use in patients with locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for PD-L1 as determined by an FDA-approved companion diagnostic (CDx) and progressing after ≥2 prior systemic therapies, including a fluoropyrimidine– and platinum-containing regimen, and, when appropriate, HER2–targeted therapy.
Nivolumab approved for sorafenib-refractory HCC
On September 22, 2017, the Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Approval was based on a 154-patient subgroup of CHECKMATE-040 (NCT 01658878), a multicenter, open-label trial conducted in patients with HCC and […]
Interested in Attending an Immunooncology Conference?
The CICS Annual Conference on Immuno Oncology is offering the most significant advances in the world of oncology. The goal of the meeting is to convey the clinical and translational advances in various areas of cancer immunology to medical oncologists, medical students, and other health professionals.
Novel Biomarker for Ipilimumab Treatment may aid Future Patient Selection in Several Malignancies
The number of different types of T-helper cells (Th) and cytotoxic T cells (CD8) may predict response to ipilimumab in several malignancies. This was concluded by Dr Juan Pablo Márquez Manríquez who presented the study at the ESMO conference on behalf of the investigators of the Sonora Cancer Research Center (CICS) in Mexico and the United States (U.S.).
IMM101 plus Gemcitabine Hopeful in Metastatic Pancreatic Cancer
A phase II proof-of-concept (POC) study investigating the safety and tolerability of immune modulator IMM-101 plus gemcitabine vs. single agent gemcitabine in advanced pancreatic ductal adenocarcinoma (PDAC) showed significant improved progression-free survival (PFS) and overall survival (OS) in metastatic patients receiving the combination treatment.
