Neoadjuvant Nivolumab/Ipilimumab Combo Effective but Toxic for Melanoma

Excerpt:

“Neoadjuvant treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated almost a tripling in objective response rate (ORR) compared with the PD-1 inhibitor alone but at the cost of significant added grade 3 adverse events (AEs) for patients with high-risk resectable melanoma, according to a small study presented at the 2017 SITC Annual Meeting.

“In the combination arm (n = 11), the ORR was 73% and 50% of patients achieved a pathological complete response (pCR). With nivolumab alone (n = 12), the ORR was 25% and the pCR rate was 25%. Unfortunately, these gains in response were accompanied by 73% of patients in the combination arm having a grade 3 AE compared with just 8% in the single-agent arm. This high level of toxicity led the researchers to close the study early, according to Sangeetha M. Reddy, MD, MSci. Reddy worked on this trial with co-investigators Rodabe Amaria, MD, and Jennifer Wargo, MD.”

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T-VEC, Ipilimumab Regimen Improves Survival in Advanced Melanoma

Excerpt:

“The combination of an oncolytic virus plus a checkpoint inhibitor improved survival among patients with advanced melanoma compared with monotherapy, according to data from a phase 2 study published in Journal of Clinical Oncology.

“Novel monotherapies, such as ipilimumab (Yervoy, Bristol-Myers Squibb) — a CTLA-4 antibody — have ‘transformed patient care in advanced melanoma,’ the researchers wrote.”

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Novel Combinations Mark Next Step for Melanoma

Excerpt:

“Immunotherapy has led a transformation for melanoma care but combinations of anti–PD-1 and CTLA-4 agents are toxic and biomarkers are not available to help personalized treatment, calling for further research into less toxic and more effective options, according to a presentation by Caroline Robert, MD, PhD, at the 2017 World Congress of Melanoma.

“At this point, the only approved immunotherapy combination remains the PD-1 inhibitor nivolumab (Opdivo) and the CTLA-4 inhibitor ipilimumab (Yervoy). However, research into combination approaches is now focusing on triplets of anti–PD-1 therapies and new checkpoints, such as IDO. Additionally, ongoing research continues to search of a biomarker of response for immunotherapy in melanoma.”

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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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Adjuvant Ipilimumab in Melanoma: Future in Doubt

Excerpt:

“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.”

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Radiation-Immunotherapy Combination Can Slow Tumor Growth for Some Patients With Metastatic Late-Stage Cancer

Excerpt:

“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).”

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Ipilimumab Shows Promise in Mutated NSCLC, but Toxicities May Limit Use

Excerpt:

“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.”

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New Clinical Trial Might Change the Standard Treatment for Melanoma

Excerpt:

“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.”

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Combination of Standard-Dose Pembrolizumab With Reduced-Dose Ipilimumab Tolerable and Effective in Advanced Melanoma

Excerpt:

“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.”

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