“Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues.
“The announcement comes after Roche in September said patients with untreated extensive-stage small cell lung cancer (SCLC) lived a median 12.3 months after getting the Tecentriq cocktail, compared to 10.3 months for those getting chemotherapy alone.
“Winning the speedy review from the U.S. Food and Drug Administration sets up possible U.S. approval for Tecentriq in this indication by March 18, the drugmaker said in a statement.”
“Lurbinectedin (Zepsyre; PM1183) plus doxorubicin demonstrated significant clinical activity as a second-line therapy for patients with small cell lung cancer (SCLC), especially when excluding refractory patients.
“In particular, patients with chemotherapy-free intervals (CTFIs) of 90 days or more induced a 53% overall response rate (ORR) and PFS of 5.7 months, according to findings that were presented at the 19th World Conference on Lung Cancer (WCLC) in Toronto, Canada.”
“A drug cocktail with Roche’s Tecentriq added two months to small-cell lung cancer patients’ lives, according to a study, aiding the Swiss group’s bid to win approval in a niche disease area before rivals that now dominate the immunotherapy market.
“Patients with untreated extensive-stage small-cell lung cancer (SCLC), where cancer has spread, lived a median 12.3 months after getting Tecentriq plus chemotherapy.”
“Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response.
“This approval for nivolumab had been granted Priority Review from the FDA. It was based on data from the SCLC cohort of the ongoing phase I/II CheckMate-032 study evaluating nivolumab monotherapy in patients who experienced disease progression after platinum-based chemotherapy.”
“In a randomized, Phase II trial led by researchers at The University of Texas MD Anderson Cancer Center, adding the PARP inhibitor veliparib to a standard chemotherapy agent improved overall response rates (ORR) in patients with small cell lung cancer (SCLC). Researchers also identified a select group of patients—those whose tumors expressed SLFN11— who also saw a progression-free survival (PFS) and overall survival (OS) benefit, suggesting a promising biomarker for the PARP-inhibitor sensitivity in SCLC.
“The study was published in Journal of Clinical Oncology. Ongoing follow-up studies are underway to confirm the results, which could result in the first new therapeutic option for this rare and aggressive lung cancer in more than three decades, said Lauren Averett Byers, M.D., associate professor of Thoracic/Head and Neck Medical Oncology.”
“The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer (SCLC) with disease progression following two or more lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.
“The sBLA is based on data from the phase 1/2 CheckMate-032 trial, in which single-agent Opdivo led to a median overall survival (OS) of 4.4 months and a one-year OS rate of 33 percent in patients with progressive SCLC following one or more prior lines of therapy. Under the priority review, the FDA is scheduled to make its decision by Aug. 16, 2018.”
“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.”
“Pembrolizumab (Keytruda) induced an overall response rate (ORR) of 33% in patients with extensive-stage small cell lung cancer (SCLC), according to findings from the open-label, phase Ib KEYNOTE-028 trial published in the Journal of Clinical Oncology.
“One patient (4.2%) experienced a complete response, 7 (29.2%) had partial responses, and 1 (4.2%) had stable disease for less than 6 months. Thirteen patients (54.2%) experienced disease progression as the best overall response.”
“Improvements in OS, but not PFS, indicate that maintenance treatment with pembrolizumab may benefit a subset of patients with small cell lung cancer, and biomarkers are needed to identify individuals in whom pembrolizumab may be effective, according to findings presented at the ASCO Annual Meeting.
” ‘The standard of care for these patients – 4 to 6 cycles of platinum plus etoposide – has not changed in the United States in the last 30 years,’ Shirish Gadgeel, MD, of the Karmanos Cancer Institute in Detroit, said during a presentation. ‘Despite a high response rate with this therapy, overall outcomes for these patients are quite poor. There is a need to identify other agents that can provide benefit in these patients.’ ”