“Nivolumab (Opdivo) has received an FDA priority review designation for patients with previously treated nonsquamous non–small cell lung cancer (NSCLC), according to the developer of the PD-1 inhibitor, Bristol-Myers Squibb (BMS). Under the expedited process, the FDA’s decision deadline is January 2, 2016.
“The FDA simultaneously granted nivolumab a breakthrough therapy designation in this setting. The priority and breakthrough designations are based on data from the phase III CheckMate-057 trial, in which second-line nivolumab reduced the risk of death by 27% versus docetaxel in patients with nonsquamous NSCLC, including a 60% risk reduction among patients with the highest levels of PD-L1 expression.
“Nivolumab was previously approved in March 2015 for patients with squamous cell NSCLC who have progressed on or after platinum-based chemotherapy.”
The biggest news in melanoma treatment from the 2015 American Society of Clinical Oncology (ASCO) annual meeting was undoubtedly the report from a large, phase III, randomized clinical trial that compared a combination of two ‘checkpoint inhibitor’ drugs—nivolumab (Opdivo) and ipilimumab (Yervoy)—with the same drugs given alone.
In the CheckMate-067 trial, 945 previously untreated patients with unresectable stage III or IV melanoma were assigned to Opdivo alone, Opdivo plus Yervoy, or Yervoy alone. Continue reading…
“An immunotherapy combination for untreated melanoma reduced the risk of death or progression by more than half as compared with a drug currently used as a standard of care, a large randomized trial showed.
“Patients treated with nivolumab (Opdivo) and ipilimumab (Yervoy) had a median progression-free survival (PFS) of 11.5 months compared with 2.9 months for ipilimumab alone and 6.9 months with nivolumab monotherapy. Median PFS with the combination and with nivolumab alone increased to 14 months — more than four times greater than the PFS of patients who received only ipilimumab — among patients whose tumors tested positive for programmed death receptor ligand 1 (PD-L1), the target of nivolumab.
“The PFS improvement came at a price of increased toxicity, as grade 3/4 adverse events occurred twice as often with the combination as with ipilimumab monotherapy, but even patients who discontinued treatment because of side effects did better with the combination, as reported here at the American Society of Clinical Oncology meeting.”
“Drugmakers including Bristol-Myers Squibb Co and Merck & Co are testing which patients will most benefit from new cancer treatments based on a protein found in their tumors, but that guide, known as a biomarker, may be too unreliable, researchers and health experts said.
“Bristol’s Opdivo and Merck’s Keytruda are both therapies designed to block a protein known as Programmed Death receptor (PD-1) that tumors use to evade the body’s natural defenses. Competitors Roche Holding, AstraZeneca and Pfizer also have similar drugs in an earlier stage of development. The drugmakers are conducting clinical trials that test patient tumors for a related protein called PD-L1.
“The new drugs are mainly aimed at patients with so-called solid tumors suffering from diseases including lung cancer and liver cancer. Lung cancer, the most common type, claims 1.8 million new cases each year worldwide. Sales of drugs to block PD-1 could reach $33 billion a year by 2022, according to Morningstar.”
“Bristol-Myers Squibb Company (NYSE:BMY) today announced results from CheckMate -017, a Phase III, open-label, randomized study evaluating Opdivo (n=135) versus docetaxel (n=137) in previously treated patients with advanced squamous non-small cell lung cancer. At one year, Opdivo demonstrated an overall survival rate of 42% versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. In the trial, Opdivo reduced the risk of death by 41%, based upon a hazard ratio of 0.59 (95% CI, 0.44-0.79; P = 0.00025). The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. Findings from CheckMate -017 were published today in The New England Journal of Medicine and presented during an oral abstract session at the 51st Annual Meeting of the American Society of Clinical Oncology (Abstract #8009).
“ ‘Historically, treatment options for lung cancer patients have been limited. The Opdivo data presented today offer patients the first major advance in the treatment of squamous non-small cell lung cancer in more than a decade,’ said David Spigel, MD, Sarah Cannon Research Institute. ‘In this study, Opdivo not only demonstrated superior overall survival and objective response rate versus chemotherapy, the standard of care, but these benefits were sustained over time. The study also showed that squamous non-small cell lung cancer has a unique biology that resulted in similar efficacy across levels of PD-L1 expression.’ “
“AstraZeneca AZN, -0.75% and MedImmune, AstraZeneca’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.
“Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumor types and tumor biology.
“MEDI4736 and tremelimumab combination shows clinical activity and tolerability in both PD-L1 positive and PD-L1 negative advanced non-small cell lung cancer (NSCLC) patients; dose confirmed for future studies
“Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC, demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.”
Memorial Sloan Kettering Cancer Center | May 31, 2015
“Treating advanced melanoma patients with either a combination of the immunotherapy drugs nivolumab (Opdivo™) and ipilimumab (Yervoy™) or nivolumab alone significantly increases progression-free survival (PFS) over using ipilimumab alone, according to new findings from researchers at Memorial Sloan Kettering Cancer Center (MSK) simultaneously presented today at the American Society of Clinical Oncology (ASCO) annual meeting and published online in the New England Journal of Medicine (NEJM). Examining specific characteristics of each patient’s tumor has also given researchers clearer understanding of which patients should receive the combination.
“These initial findings from the phase III clinical trial confirm the results of the phase II trial, presented just weeks ago at the American Association of Cancer Research annual meeting in Philadelphia and published by MSK researchers online in NEJM.”