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.
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.
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.
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.
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.
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.
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).
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.
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 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.
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.
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.
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.
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.
On July 13, the FDA approved enzalutamide (Xtandi©, Astellas), for use in patients with castration-resistant prostate cancer (CRPC).
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.
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.
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.
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).
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.
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.
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.
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).
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?
The FDA granted regular approval to dabrafenib (Tafinlar®, Novartis) and trametinib (Mekinist®, Novartis) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
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).
edit+xClone Element
FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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)
The FDA granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
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.
On April 10, the FDA approved everolimus tablets for oral suspension (Afinitor Disperz®, Novartis) for the adjunctive treatment of adult and pediatric patients ≥2 years with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
There is no excerpt because this is a protected post.
Crizotinib in Asian NSCLC patients with ROS1 alterations was associated with a 71.7% objective response rate (ORR) with a median duration of response (DOR) of 19.7 months (95% CI, 14.1 months – not reached). Learn more about the results with crizotinib in East-Asian non-small cell lung cancer (NSCLC) patients harbouring c-ros oncogene 1 (ROS1) rearrangements.
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.
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.
There is no excerpt because this is a protected post.
November turns purple for pancreatic cancer awareness. Focus is on one of the most difficult-to-treat tumours with the final objective: to double the survival of pancreatic cancer by 2020. What is your risk to develop pancreatic cancer? And how likely are you to get cured of the disease?
Can chemotherapy be avoided in women with hormone-sensitive breast cancer? This is a prominent question in the treatment of breast cancer around the globe.
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.
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 […]
There is no excerpt because this is a protected post.
One in six women with early, operable breast cancer may not need years of adjuvant hormonal therapy after primary treatment. This was the conclusion of a recent study published in JAMA (the Journal of the American Medical Association) Oncology.
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.
Cyclin-dependent Kinase 4 and 6 (CDK4/6) inhibitors have shown clinical activity in patients with endocrine-resistant metastatic breast cancer. During the European Society for Medical Oncology (ESMO) Annual Meeting 2016, significant updates on studies with CDK4/6 inhibitors ribociclib, palbociclib and abemaciclib were presented.
There is no excerpt because this is a protected post.
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.).
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
Increased cancer awareness improves survival, according to a recent study by Cancer Research UK (CRUK) published in the British Journal of Cancer (BJC). The researchers matched cancer symptom awareness from a population-based survey in over 35,000 people across the UK with the cancer registry.
In women with stage IIIC or IV ovarian cancer, primary cytoreductive surgery (PCS) may be preferred when there is a high chance to achieve cytoreduction to <1 cm with acceptable morbidity. This was concluded by an expert panel who published clinical guidelines in the Journal of Clinical Oncology (JCO) this week.
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.
At the American Association for Cancer Research, 2014 annual meeting (AACR) Richard Finn presented the results of the PALOMA-1 study with Ibrance® (palbociclib), an oral inhibitor of cyclin-dependent kinase 4/6 (CDK4/6). Based on the results of this Phase 2 study, palbociclib was recently approved by the United States Drug and Food Administration (U.S. FDA). What is the current level of evidence on palbociclib in approved indications?
Recent studies have shown new possible applications for Ki67. Huh et al. showed that low Ki67 levels in healthy breast tissue correlated with a lesser lifetime chance of breast cancer. Another study by Arnedos and colleagues concluded that palbociclib was able to invoke a significant Ki67-level drop. After a decade of Ki67-controversies, these results put the marker back in the spotlight.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.
©Alex011973 / 123RF Stock Photo
©United States Food and Drug Agency
© srr283/123RF
© abhijith3747/123RF
©eraxion / 123RF Stock Photo
©
© 
bravajulia / 123RF Stock Photo
Hywards / 123RF Stock Photo
krishnacreations / 123RF Stock Photo
©