“Immunotherapy is quickly becoming a mainstay in the frontline setting for the treatment of patients with metastatic non–small cell lung cancer (NSCLC).
“In October 2016, the FDA approved the PD-1 inhibitor pembrolizumab (Keytruda) as a first-line treatment for patients with metastatic NSCLC whose tumors have at least 50% PD-L1 expression and who do not harbor EGFR or ALK mutations.”
“The FDA granted priority review to a supplemental biologics license application for pembrolizumab in combination with chemotherapy for first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer, according to the drug’s manufacturer.
“The application seeks approval of pembrolizumab (Keytruda, Merck), an anti–PD-1 therapy, in combination with pemetrexed and carboplatin regardless of patients’ PD-L1 expression, provided they have no EGFR or ALK mutations.
“The FDA is expected to make a decision by May 10.”
“Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the decision to advance the clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 inhibitor, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.
“With the expansion of the clinical development program, the companies plan to initiate pivotal studies of epacadostat in combination with KEYTRUDA in four additional tumors: non-small cell lung cancer, renal cell carcinoma, bladder cancer and squamous cell carcinoma of the head and neck. Presentations of data from the ongoing studies of epacadostat in combination with KEYTRUDA, which support this decision, are expected at upcoming medical meetings.”
“A leading-edge immunotherapy clinical trial at UConn Health’s Carole and Ray Neag Comprehensive Cancer Center has packed a one-two punch, successfully controlling a patient’s advanced lung cancer using the combined power of two immunotherapy drugs.
“For 50 years Michel Gueret, 67, of Canton was a heavy smoker. That is until May 2012, when he received the devastating news that he had advanced lung cancer while hospitalized for a collapsed lung at UConn John Dempsey Hospital.”
“Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced new interim data investigating Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in combination with Eisai’s microtubule dynamics inhibitor, HALAVEN® (eribulin) in patients with metastatic triple-negative breast cancer (TNBC). Findings presented during the 2016 San Antonio Breast Cancer Symposium (SABCS) were based on interim data from 39 evaluable patients and showed an overall response rate (ORR) of 33.3% (n=13/39; 95% CI, 19.5-48.1), with one complete response and 12 partial responses (Abstract #: P5-15-02). ORR was similar between PD-L1-positive and -negative cohorts [PD-L1 positive=29.4% (n=5/17; 95% CI, 11.1-51.1); PD-L1 negative=33.3% (n=6/18; 95% CI, 14.1-54.6)]. HALAVEN and KEYTRUDA are not approved for use in combination.”
“Immunotherapy is now offering hope even in one of the most aggressive cancers of all, malignant pleural mesothelioma.
“Malignant mesothelioma is usually diagnosed at a late stage and is essentially incurable. The median overall survival is approximately 12 months with first-line chemotherapy, and median survival with second-line therapy, which has not yet been adequately defined, is typically less than 10 months.
“Early clinical results with the programmed cell death (PD) inhibitors nivolumab (Opdivo, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck & Co) show response, yielding survival rates that appear to be improvements on what has been seen historically with chemotherapy.”
“Based on encouraging efficacy signals and safety data from separate trials exploring the PD-1 inhibitor pembrolizumab (Keytruda) and the PD-L1 inhibitor durvalumab (MEDI4736), there is a role for checkpoint inhibitors in the treatment of glioblastoma multiforme (GBM). Data from the studies were reported by David Reardon, MD, at the 21st Society for Neuro-Oncology (SNO) Annual Scientific Meeting.
“Reardon said that these results mark important firsts in the field: ‘There has been a lot of anticipation regarding the role of checkpoint inhibitors for glioblastoma and whether we’ll see results in any way similar to the exciting results that have been observed in other cancer indications with this new class of cancer therapeutics.’ ”
“Merck & Co has won U.S. approval to market its immunotherapy Keytruda for use in previously untreated lung cancer patients two months ahead of schedule, making it the only such drug cleared for first-line treatment.
“The green light from the Food and Drug Administration (FDA), announced by the U.S. drugmaker late on Monday, confirms Merck’s leading position in the hot area of medicines that fight tumors by harnessing the body’s immune system.
“Keytruda’s latest approval is for treating first-line metastatic non-small cell lung cancer (NSCLC) in patients with high-levels of a protein called PD-L1, which makes them more receptive to immunotherapy.”
Last year, the U.S. Food and Drug Administration (FDA) approved two anti-PD-1 checkpoint inhibitors, a type of immunotherapy, for treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has progressed after first-line treatment with chemotherapy. Now, the manufacturers of both drugs, pembrolizumab (made by Merck) and nivolumab (made by Bristol-Myers Squibb; BMS) are intent on expanding the indications for use of their drugs. To this end, they have conducted clinical trials testing each as a first-line treatment (i.e., in previously untreated patients), comparing them to standard chemotherapy. Continue reading…