Opdivo Alone or Combined with Yervoy Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer Patients with High Tumor Mutation Burden, in Exploratory Analysis from Phase 1/2 Study CheckMate -032

Excerpt:

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.”

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Pembrolizumab Shows Promise in Small Cell Lung Cancer

Excerpt:

“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.”

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Maintenance Pembrolizumab Benefits Certain Patients With Small Cell Lung Cancer

Excerpt:

“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.’ ”

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Proton-Beam Therapy in Limited-Stage SCLC Shows Promising Efficacy

Excerpt:

“Proton-beam therapy (PBT) was found to be safe for patients with limited-stage (LS) small-cell lung cancer (SCLC) in the first prospective registry study of the therapy, with only a small number of high-grade toxicities.

” ‘Radiation therapy is essential for the management of limited-stage SCLC,’ wrote study authors led by Jean-Claude M. Rwigema, MD, of the Hospital of the University of Pennsylvania in Philadelphia. ‘When it is given with concurrent chemotherapy, radiation therapy can result in substantial toxicities.’ PBT can reduce the exposure to nearby organs at risk in non–small-cell lung cancer, and is under substantial investigation in that setting; before the new study, though, only a six-patient case series had examined its use in SCLC.”

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Video: Nivolumab With Ipilimumab for Small Cell Lung Cancer

Excerpt:

“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).”

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Adding Palifosfamide in Extensive-Stage SCLC Did Not Increase Survival

Excerpt:

“Adding palifosfamide to carboplatin and etoposide failed to improve survival over the latter two agents alone in patients with extensive stage (ES) small-cell lung cancer (SCLC), according to a new study.

” ‘Platinum doublet chemotherapy has been the standard of care first-line regimen in patients with ES SCLC for the last 3 decades,’ wrote study authors led by Shadia I. Jalal, MD, of the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis. ‘Unfortunately, disease relapse occurs in all patients, and second-line chemotherapy options lead to short responses. Novel first-line therapies continue to be urgently needed.’ ”

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Statins Show No Survival Benefit in Small-Cell Lung Cancer

Excerpt:

“Patients with small-cell lung cancer derived no survival benefit from cholesterol-lowering medication, according to a phase 3 randomized, double blind, multicenter, placebo-controlled study published in Journal of Oncology.

” ‘There’s no reason for people to stop taking statins to manage their cholesterol, but it’s extremely unlikely, for patients with small-cell lung cancer, that taking statins will make any difference to their cancer treatment outcome,’ Michael J. Seckl, MD, professor of molecular cancer medicine at Imperial College London, said in a press release. ‘Because all statins work in a similar way to lower cholesterol, it’s relatively unlikely that statins other than pravastatin would have a different, more beneficial effect.’ ”

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Rovalpituzumab Tesirine Active and Safe in Small Cell Lung Cancer

Excerpt:

“Rovalpituzumab tesirine (Rova-T), a DLL3-targeted antibody-drug conjugate, demonstrated encouraging single-agent antitumor activity with a manageable safety profile in the treatment of patients with recurrent small cell lung cancer (SCLC), according to the results of a phase I study published in The Lancet Oncology.

“Eleven of 60 assessable patients (18%) who received an active dose of Rova-T (0.2 mg/kg or 0.4 mg/kg every 3 weeks or 0.3 mg/kg or 0.4 mg/kg every 6 weeks) achieved a confirmed objective response, and 30 patients (50%) had stable disease. The median progression-free survival (PFS) was 2.8 months (95% CI, 2.5-4.0).”

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G1 Therapeutics to Evaluate Trilaciclib (G1T28) in Combination with Immune Checkpoint Inhibitor in Small-Cell Lung Cancer

Excerpt:

“G1 Therapeutics, Inc., a clinical-stage oncology company, announced today a clinical trial collaboration with Genentech, a member of the Roche Group. A Phase 2 clinical trial is expected to begin in the first half of 2017 and will evaluate the combination of Genentech’s immune checkpoint, anti-PD-L1 antibody Tecentriq® (atezolizumab) with G1’s CDK4/6 inhibitor trilaciclib (G1T28) as a first-line treatment for patients with small-cell lung cancer (SCLC) receiving chemotherapy.”

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