Adjuvant Nivolumab Granted FDA Approval for Melanoma

Excerpt:

“Nivolumab (Opdivo) has received FDA approval for the adjuvant treatment of patients with completely resected melanoma with lymph node involvement or metastatic disease.

“The approval is based on findings of the randomized phase III CheckMate-238 trial, in which the recurrence-free survival (RFS) rate at 18 months with nivolumab was 66.4% (95% CI, 61.8%-70.6%) compared with 52.7% (95% CI, 47.8%-57.4%) for ipilimumab (Yervoy) in patients with stage IIIB/C or stage IV melanoma after surgery. There was a 35% reduction in the risk of recurrence or death with the PD-1 inhibitor versus the CTLA-4 inhibitor (HR, 0.65; 95% CI, 0.53-0.80; P <.0001).”

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NKTR-214/Nivolumab Combination Shows Promise in Early Study

Excerpt:

“The combination of the CD122-biased cytokine NKTR-214 and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72% for patients with advanced cancers, according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.

“The dose escalation trial enrolled patients in the first- or second-line setting with advanced non–small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma. The objective response rates (ORR) by RECIST criteria ranged from 46% to 75% across tumor types. Additionally, the combination was tolerable, with no discontinuations attributed to adverse events (AEs).”

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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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Immune-Related Adverse Events Predict Efficacy of Nivolumab in NSCLC

Excerpt:

“While immunotherapy with programmed death receptor 1 (PD-1) inhibiting antibodies has revolutionized the treatment of non-small cell lung cancer (NSCLC), use of these agents comes at the cost of potential serious immune-related adverse events (irAEs). In melanoma, development of cutaneous irAEs, such as rash and vitiligo, during treatment with PD-1 inhibitors has been shown to be associated with survival benefit, suggesting that early onset of irAEs may predict treatment outcomes. However, in NSCLC, the predictive value of immunotherapy-related toxicity as a clinical marker for efficacy to PD-1 inhibition is unknown.  A multi-institution retrospective study investigated the relation between the development of irAEs and efficacy of PD-1 inhibitors in 134 patients with advanced or recurrent NSCLC who received second-line treatment with nivolumab. The primary outcome for this analysis was progression-free survival (PFS) according to the development of irAEs in a 6-week landmark analysis.”

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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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FDA Grants Priority Review to Opdivo for Resected, High-Risk Melanoma

Excerpt:

“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.”

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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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Addition of Stereotactic Ablative Radiotherapy to Nivolumab Improves Lung Cancer Survival

Excerpt:

“The combination of stereotactic ablative radiotherapy plus anti-PD-1 therapy improved survival among patients with advanced lung cancer, according to a retrospective analysis presented at the International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology.

“Immune checkpoint inhibitors have improved outcomes in non-small cell lung cancer. However, the absolute improvement over docetaxel is only 3 to 5 months for median OS and 15% to 20% for overall response rate.”

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Relatlimab/Nivolumab Combo Active in Melanoma After PD-1/PD-L1 Therapy

Excerpt:

“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.”

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