“Bristol-Myers Squibb Company (NYSE:BMY) today announced data evaluating Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) in previously treated small cell lung cancer (SCLC) patients whose tumors were evaluable for tumor mutation burden (TMB), from the Phase 1/2 CheckMate -032 trial. The primary objective of this trial was objective response rate (ORR) as assessed by a blinded independent central review (BICR), for which results were previously presented; in the pooled intent-to-treat (ITT) population (n=401), the ORR was 11% with Opdivo alone and 22% with the combination. Among the ITT population, 211 (53%) patients had an evaluable TMB result for these analyses and were divided into subgroups of high, medium and low levels of TMB.”
“The future of adjuvant ipilimumab (Yervoy, Bristol-Myers Squibb) for the treatment of resected stage III melanoma could be in doubt, as a combination of ‘astronomically high’ costs and better outcome data with another treatment threaten its position as the standard of care, argues an expert.
“Ipilimumab, a monoclonal antibody that blocks CTLA-4, was shown to significantly improve recurrence-free and overall survival vs placebo when used after surgery. These data, from the EORTC 18071 trial, led to its approval by the US Food and Drug Administration (FDA) as an adjuvant therapy for patients with stage III melanoma in October 2015. This extended its original approval in 2011 to treat late-stage melanoma in patients who are not candidates for surgery.”
American Society for Radiation Oncology | Sep 24, 2017
“A new study involving patients with stage IV cancer finds that treatment with radiation therapy and immunotherapy can halt the growth of tumors by stimulating the body’s immune system to attack the cancer. In the phase II trial, patients with end-stage cancer that had spread to the lungs or liver demonstrated a favorable response to the combined treatment. Between 30 and 60 percent of the patients, depending on the treatment arm, found that their cancer stopped spreading. Findings will be presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).”
“The addition of ipilimumab to targeted therapy for the treatment of EGFR- and ALK-mutated non-small cell lung cancer demonstrated improved survival despite dose-dependent toxicities, according to results from a phase 1b trial presented at the International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology.
“Ipilimumab (Yervoy, Bristol-Myers Squibb), a CTLA-4 inhibitor, has demonstrated long-term responses in patients with melanoma; however, the drug is associated with a high rate of grade 3 and grade 4 immune-related adverse events.”
“In a head-to-head comparison of two immunotherapy drugs used to prevent relapse in certain patients with advanced melanoma, one treatment was the clear winner — and it’s not the one that most people get.
“The international study, released Sunday, involved 900 patients whose tumors were removed by surgery but who remained at high risk of recurrence of melanoma, an often aggressive form of skin cancer.”
“The combination of the programmed death receptor 1 (PD-1) inhibitor nivolumab at a reduced dose (1 mg/kg) with the cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor ipilimumab at standard dose (3 mg/kg) for four doses followed by standard-dose nivolumab alone is a standard of care for patients with advanced, previously untreated melanoma. This is based on results from the phase III CheckMate-067 trial that confirmed combination therapy is significantly more effective than single-agent nivolumab or ipilimumab. However, improvement in efficacy is associated with increased treatment-related grade 3/4 adverse events and treatment discontinuation in nearly 40% of patients.”
“Matthew D. Hellmann, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the CheckMate-032 study, which explored nivolumab (Opdivo) with or without ipilimumab (Yervoy) for patients with small cell lung cancer (SCLC).”
“The addition of T-VEC (T-VEC; Imlygic), a herpes simplex virus 1-based oncolytic virus, to CTLA-4 inhibitor ipilimumab (Yervoy) improves the objective response rate (ORR) in patients with unresected stage IIIb to IV melanoma, according to findings presented at the 7th European Post-Chicago Melanoma/Skin Cancer Meeting.
“T-VEC was the first approved oncolytic virus therapy in Europe, the United States, and Australia, and its efficacy was previously demonstrated in a phase III trial comprising patients with advanced unresectable melanoma.”
“Bristol-Myers got a much-needed boost with the earlier-than-expected news that Opdivo beat out Yervoy in a Phase III study focused on a particular niche for adjuvant melanoma therapy. And an analyst who’s been following the data says it could be worth a billion dollars in added annual sales.
“The big biotech says an interim analysis of Checkmate-238 provided researchers with proof that the PD-1 drug outperformed Yervoy, Bristol-Myers’ CTLA-4 drug, among advanced Stage IIIb or IV patients, cutting the recurrence rate for those who have undergone surgery. There are no bottom line numbers in the statement, but Bristol-Myers says they’ll be able to release data at an upcoming conference to show that Opdivo provided a significantly lower risk of disease recurrence.”