Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…


Two-Year Overall Survival Data from Two Pivotal Opdivo® (nivolumab) Trials Demonstrate Sustained Benefit In Patients with Advanced Non-Small Cell Lung Cancer

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) announced today two-year overall survival data from two pivotal Phase 3 studies evaluating Opdivo (nivolumab) versus docetaxel in previously treated metastatic non-small cell lung cancer (NSCLC). Opdivo continued to demonstrate improved overall survival (OS), the primary endpoint for both studies, at the landmark two-year time point. In CheckMate -057, a trial in previously treated non-squamous NSCLC, 29% of patients treated with Opdivo were alive at two years (n=81/292) versus 16% of those treated with docetaxel (n=45/290) (HR: 0.75 [95% CI: 0.63, 0.91]). In CheckMate -017, a trial in previously treated squamous NSCLC, 23% of patients treated withOpdivo were alive at two years (n=29/135) versus 8% of those treated with docetaxel (n=11/137) (HR: 0.62 [95% CI: 0.47, 0.80]). In Checkmate -057 and -017, treatment-related adverse events (AEs) occurred in 71% and 61% of Opdivo-treated patients. The safety profile of Opdivo at two years was consistent with previous reports of data from both studies.”

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ELCC 2016 News: Updates from CheckMate 063 and 017 Trials Confirm Nivolumab Efficacy in Patients with Advanced Platinum-Refractory Squamous NSCLC

Excerpt:

“The baseline serum cytokine levels of platinum pretreated patients with advanced squamous non-small cell lung cancer (NSCLC) altered the efficacy of immunotherapy with nivolumab, a fully human IgG4 antibody inhibiting the programmed death-1 (PD-1) immune checkpoint.

“Updated findings from the phase II CheckMate 063 trial of nivolumab and phase III CheckMate 017 trial of nivolumab versus docetaxel in patients with advanced platinum-refractory squamous NSCLC were submitted by Dr Hervé Lena, Service de Pneumologie, Centre Hospitalier Universitaire de Rennes, Rennes, France and colleagues, including Suresh Ramalingam who presented the results at the European Lung Cancer Conference (ELCC), held in Geneva, Switzerland, 13 to 16 April, 2016.”

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Opdivo (Nivolumab) Demonstrates Superior Survival Compared to Standard of Care (Docetaxel) for Previously-Treated Squamous Non-Small Cell Lung Cancer in Phase III Trial

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.’ “


Opdivo so Much Better than Chemotherapy for NSCLC That a Clinical Trial Is Stopped Early

The gist: Researchers found that the drug nivolumab (Opdivo) worked so much better than chemotherapy for certain lung cancer patients that they stopped a clinical trial early. The researchers were testing Opdivo in people with advanced, squamous cell non-small cell lung cancer (NSCLC) that had been previously treated. Opdivo is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer.

Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase 3 study evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company will share these data – which for the first time indicate a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer – with health authorities.

“CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -017 data and work with investigators on the future presentation and publication of the results.”