ASCO 2016: Nivolumab Alone or in Combination With Ipilimumab Active in Recurrent Small Cell Lung Cancer

Excerpt:

“A study presented by Antonia et al at the 2016 ASCO Annual Meeting (Abstract 100) showed that utilizing the immunotherapeutic agents nivolumab (Opdivo) and ipilimumab (Yervoy) could lead to more effective treatment options for patients with small cell lung cancer (SCLC) who have progressed after prior chemotherapy.

“Studies have shown that nivolumab combined with ipilimumab results in improved antitumor activity when compared with either agent alone. The U.S. Food and Drug Administration recently approved this two-drug combination for the treatment of advanced melanoma.

“Given the promising activity of the immunotherapy combination in melanoma, researchers wanted to assess whether this regimen could also be effective in other types of tumors with few to no therapeutic options.”

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Nivolumab/Ipilimumab Frontline Response Nears 60% in PD-L1+ NSCLC

Excerpt:

“Upfront treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated an objective response rate (ORR) of 57% in patients with PD-L1-positive advanced non–small cell lung cancer (NSCLC), according to updated pooled findings from the phase Ib CheckMate-012 study presented at the 2016 ASCO Annual Meeting.

“In the 3-arm study, patients received nivolumab alone or in combination with ipilimumab every 6 weeks (Q6W) or every 12 weeks (Q12W). Across the full population, which was not selected based on PD-L1 expression, single-agent nivolumab had an ORR of 23%. In the combination arms, the ORRs were 47% and 39%, in the Q12W and Q6W arms, respectively.”

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Expert Examines Immunotherapy Potential in Small Cell Lung Cancer

Excerpt:

“Several ongoing clinical trials are examining the efficacy and safety of immunotherapy agents in patients with small cell lung cancer (SCLC), explains David P. Carbone, MD, PhD.

“Two early phase studies have already shown encouraging results. In the phase I/II CheckMate-032 trial, pretreated patients with SCLC received monotherapy with the PD-1 inhibitor nivolumab (Opdivo) or the combination of nivolumab plus the CTLA-4 inhibitor ipilimumab (Yervoy). Data showed that the median progression-free survival (PFS) was 3.35 months with the combination and 1.38 months with nivolumab alone. Median OS was 7.75 months with the combination and 3.55 months with single-agent therapy. The objective response rate (ORR) with the combination was 31.1%.

“In the phase Ib KEYNOTE-028 trial, the PD-1 inhibitor pembrolizumab (Keytruda) had an ORR of 29.2% (95% CI, 12.6-51.1) in patients with SCLC who had prior chemotherapy.”

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Understanding the Future of Immunotherapy in Melanoma

Excerpt:

“While there have been many recent advances in the field of melanoma regarding immunotherapy, there is much more is to come, says Antoni Ribas, MD, PhD.

“One notable breakthrough, which demonstrates the significant potential of the field, is the phase II CheckMate-069 trial, which examined the combination of ipilimumab (Yervoy) and nivolumab (Opdivo). The combination showed a 42% improvement in overall survival (OS) when compared with ipilimumab as a monotherapy.

“In an interview with Targeted Oncology, Ribas, a professor of Medicine, Surgery, and Molecular and Medical Pharmacology at the University of California, discusses what these data mean and where the field of immunotherapy in melanoma is headed.”

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Melanoma Combinations: Going Beyond Ipilimumab/Nivolumab

Excerpt:

“Ipilimumab (Yervoy) and nivolumab (Opdivo) may be getting plenty of buzz; however, the dual immunotherapy regimen is certainly not the only combination making a significant impact in the treatment of patients with advanced melanoma, explains Omid Hamid, MD.

“ ‘On the heels of the ipilimumab/nivolumab combination having such a high response rate and while we are still awaiting survival data, we have been looking to find other standard combinations for advanced melanoma,’ says Hamid, chief of Translational Research and Immunotherapy, director of Melanoma Therapeutics, The Angeles Clinic. ‘That is not to say that ipilimumab/nivolumab is not a standard; it is a breakthrough in showing that we can combine these types of agents and have good outcomes. However, it makes a lot of sense to look at these other combinations.’ ”

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Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Yervoy® (ipilimumab) for Treatment of Advanced Melanoma

Excerpt:

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults. The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Opdivo monotherapy is already approved by the EC for advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC), and was recommended for approval by the CHMP in February for previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma (RCC).”

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Talimogene Laherparepvec, Pembrolizumab Combination Safely Treats Advanced Melanoma

Excerpt:

“Patients with advanced unresectable melanoma can safely receive combination therapy with full doses of talimogene laherparepvec and pembrolizumab, according to study results presented at HemOnc TodayMelanoma and Cutaneous Malignancies.

“In previous studies, talimogene laherparepvec (Imlygic, Amgen) — a herpes simplex virus-1-based oncolytic immunotherapy — significantly improved durable response rate in patients with advanced melanoma. Also, pembrolizumab (Keytruda, Merck) — an anti–PD-1 antibody — showed superiority over ipilimumab (Yervoy, Bristol Meyers Squibb) in patients with stage III or IV melanoma.

“Both drugs appeared tolerable and demonstrated nonoverlapping adverse event profiles…”

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After Decades of Research, Potential for TILs in Melanoma Is Higher Than Ever

“Tumor infiltrating lymphocyte (TIL) technology represents an intriguing way of overcoming the immunosuppressive power of cancer, according to Jeffrey S. Weber, MD, PhD.

“Weber provided an overview of the technology and discussed its potential benefit to oncologists and oncology professionals in a lecture presented by Targeted Oncology on February 19, 2016.

“ ‘It’s yet another way of inducing remissions of long duration using an immunotherapeutic approach that’s different than ipilimumab and different than nivolumab or pembrolizumab,’ said Weber, the deputy director of the Laura and Isaac Perlmutter Cancer Center, co-director of the Melanoma Program, and head of Experimental Therapeutics at NYU Langone Medical Center. ‘It’s got its own toxicity, but you can fail this therapy and respond to ipilimumab or respond to nivolumab or pembrolizumab. You can fail nivolumab or pembrolizumab or ipilimumab and respond to this—they’re not cross-reactive.’ “


Opdivo Plus Yervoy Gets FDA OK for Melanoma

“Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.

“The indication includes both BRAF-wild type and BRAF-mutant melanoma. At the same time, the FDA expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma.

“Granted by the FDA’s accelerated approval process, the indication is the seventh for nivolumab, both indications leave the door open for the FDA to request confirmatory data or clinical trials. The approvals increase the number of nivolumab indications to seven, including four in melanoma, all granted since late 2014.”