“The FDA granted priority review to nivolumab for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection, according to the drug’s manufacturer.
“Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, previously received breakthrough therapy designation for this indication.”
“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.”
“Triplet therapy for advanced, BRAF V600-mutant melanoma led to objective responses in 73% of a small group of patients enrolled in a phase I trial, according to updated results reported at the 2017 ESMO Annual Congress in Madrid.
“Ongoing follow-up in the trial showed that 11 of 15 patients responded to the combination of pembrolizumab (Keytruda), dabrafenib (Tafinlar), and trametinib (Mekinist). Seven of the 11 responding patients had not progressed after a median follow-up of 20 months. ‘Updated results of the phase I portion of the KEYNOTE-022 trial confirmed previously reported efficacy of this triplet combination,’ said Antoni Ribas, MD, PhD, a professor of medicine, surgery, and molecular and medical pharmacology at the University of California at Los Angeles. ‘The results demonstrated durability of responses. No late or unexpected toxicities occurred with longer follow-up. The randomized phase II portion of KEYNOTE-022 is ongoing.’ ”
“Half of patients with melanoma who progressed on anti–PD-1/PD-L1 therapy benefited from the combination of nivolumab (Opdivo) and the LAG-3 inhibitor relatlimab (BMS-986016), data from a dose-expansion study showed.
“The combination led to objective responses in 7 of 61 evaluable patients, increasing to 18% in a subgroup of patients LAG-3–positive tumors. Half of all patients treated and two-thirds of those patients with LAG-3–positive tumors derived clinical benefit, as reported at the 2017 ESMO Congress.”
“Array BioPharma (ARRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Applications (NDAs) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In addition, the FDA informed Array that based on their preliminary review of the applications they have not identified any potential review issues, and that they are not currently planning to hold an advisory committee meeting to discuss these NDAs. Array completed its NDA submissions at the end of June 2017based on findings from the pivotal Phase 3 COLUMBUS trial.”
“A majority of patients with advanced melanoma responded to the combination of pembrolizumab (Keytruda) and the investigational IDO1 inhibitor epacadostat, as reported at the European Society of Medical Oncology congress in Madrid.
“In phase I/II results from the ECHO-202/KEYNOTE-037 trial, the combination induced objective responses in 29 of 53 (55%) efficacy-evaluable untreated patients, including seven complete responses. Twenty-two of 38 evaluable patients (58%) responded to the recommended phase II dose of epacadostat (100 mg).”
“Swiss drugmaker Novartis notched a trial win for its drug cocktail against skin cancer on Monday, while a rival treatment from Roche with slipping sales failed in a separate study with a similar patient group.
“All the medicines were tested in melanoma patients who had undergone surgery to cut out tumors and had a genetic mutation called BRAF, making them likely to respond to the targeted cancer pills. Patients with BRAF mutations constitute around half of the melanoma population.”
“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.”
“Scientists are stepping up the hunt for better diagnostic tests to predict if cancer patients will benefit from costly modern immunotherapy drugs, which are transforming cancer care but remain a hit-and-miss affair.
“Research presented at Europe’s biggest oncology congress in Madrid adds to evidence that patients with an above average number of genetic mutations in their tumors have a better chance of responding to the new treatments, and drugmakers are racing to confirm the idea.”