Merck Wins Early U.S. Approval for Keytruda in Untreated Lung Cancer

Excerpt:

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.”

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War of the Checkpoint Inhibitors: Anti-PD-1 Drugs Move into First-Line Treatment in NSCLC


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…


UPDATE 1-Novartis Works with Bristol-Myers Squibb to Test Lung Cancer Drugs

The gist: Combining existing drugs can sometimes result in new, more effective cancer treatments. As we posted on our Need to Know blog today, lung cancer researchers are testing drug combinations that involve immunotherapies—treatments that boost the immune system to fight cancer. Now, two drug companies have announced that they will be testing combinations of their lung cancer drugs. An immunotherapy drug called Opdivo will be combined with targeted drugs. The combinations will be tested in clinical trials with volunteer patients who have late-stage non-small cell lung cancer (NSCLC). It is hoped that the combinations will work better than any of the drugs alone.

“Swiss pharma group Novartis AG said on Monday it would work with Bristol-Myers Squibb Co to test the U.S. drugmaker’s immuno-oncology drug Opdivo in combination with three of its own experimental lung cancer drugs.

“The clinical collaboration will help Novartis advance its efforts in the field of immunotherapy, one of the hottest areas in biotech right now, following the acquisition of CoStim Pharmaceuticals Inc this year, the drugmaker said.

“Novartis currently lags rivals such as Roche, Merck , AstraZeneca and Bristol-Myers in the race to develop immunotherapies – drugs that fight cancer by harnessing the body’s immune system.

“The two companies will test the combination of three molecularly targeted compounds with Bristol-Myers’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in phase I and II studies, Novartis said, adding it would conduct both studies.

” ‘Preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients,’ Alessandro Riva, global head of Novartis oncology development and medical affairs, said in the statement.”


Anti-PD-1 Antibody MK-3475 Advances Into Multiple Tumor Types

“Merck announced the signing of three separate clinical collaboration agreements to evaluate the potential of its investigational anti-PD-1 immunotherapy MK-3475 across multiple tumor types.  The agreements, of which financial terms were not disclosed, were signed through subsidiaries with Amgen Inc., Incyte Corporation, and Pfizer Inc.

“As part of the new collaborations, Merck will begin several clinical trials. In these phase I/II studies, MK-3475 will be explored in combination with axitinib in renal cell carcinoma, talimogene laherparepvec (T-VEC) in previously untreated advanced melanoma, the immunotherapy INCB24360 in previously treated metastatic recurrent non-small cell lung cancer (NSCLC), and PF-2566 in multiple cancer types. Separate from these collaborations, Merck announced that the safety and efficacy of MK-3475 monotherapy would be evaluated in a phase I “signal finding” study in 20 PD-L1-positive solid tumor types not previously studied.”


Anti-PD-1 Antibody MK-3475 Advances Into Multiple Tumor Types

“Merck announced the signing of three separate clinical collaboration agreements to evaluate the potential of its investigational anti-PD-1 immunotherapy MK-3475 across multiple tumor types.  The agreements, of which financial terms were not disclosed, were signed through subsidiaries with Amgen Inc., Incyte Corporation, and Pfizer Inc.

“As part of the new collaborations, Merck will begin several clinical trials. In these phase I/II studies, MK-3475 will be explored in combination with axitinib in renal cell carcinoma, talimogene laherparepvec (T-VEC) in previously untreated advanced melanoma, the immunotherapy INCB24360 in previously treated metastatic recurrent non-small cell lung cancer (NSCLC), and PF-2566 in multiple cancer types. Separate from these collaborations, Merck announced that the safety and efficacy of MK-3475 monotherapy would be evaluated in a phase I “signal finding” study in 20 PD-L1-positive solid tumor types not previously studied.”


Anti-PD-1 Antibody MK-3475 Advances Into Multiple Tumor Types

“Merck announced the signing of three separate clinical collaboration agreements to evaluate the potential of its investigational anti-PD-1 immunotherapy MK-3475 across multiple tumor types.  The agreements, of which financial terms were not disclosed, were signed through subsidiaries with Amgen Inc., Incyte Corporation, and Pfizer Inc.

“As part of the new collaborations, Merck will begin several clinical trials. In these phase I/II studies, MK-3475 will be explored in combination with axitinib in renal cell carcinoma, talimogene laherparepvec (T-VEC) in previously untreated advanced melanoma, the immunotherapy INCB24360 in previously treated metastatic recurrent non-small cell lung cancer (NSCLC), and PF-2566 in multiple cancer types. Separate from these collaborations, Merck announced that the safety and efficacy of MK-3475 monotherapy would be evaluated in a phase I “signal finding” study in 20 PD-L1-positive solid tumor types not previously studied.”


Patient’s Perspective: Erin Youngerberg’s Take on Melanoma


Erin Youngerberg was diagnosed with melanoma in October, 2010, at age 32 years. Well-traveled and an avid photographer, she grew up in Minnesota, went to college and worked in Milwaukee, then made her way east, living in Ohio and North Carolina before ending up in Jersey City, just outside of New York City. After her diagnosis, she started a blog to keep folks back home updated. Called ‘Melanoma and the City,’ it tells the whole story: from appointments at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City to various city adventures; from treatment side effects to recipes for quinoa and tacos. Erin has also found herself dedicated to spreading the word about melanoma awareness. We asked her to take us through her melanoma story. Continue reading…


Merck Announces Breakthrough Therapy Designation for Lambrolizumab an Investigational Antibody Therapy for Advanced Melanoma

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.”


Preclinical Study Indicates Potential for Novel Inhibitor to Overcome Drug Resistance Induced by RAF, MEK Inhibitors

WASHINGTON, D.C. — A new class of investigational medicines may help to treat patients with cancers driven by mutations in genes such as BRAF or KRAS/NRAS, including those patients who have become resistant to therapies that target BRAF directly,…