Single-Agent Nivolumab Withdrawn for Hepatocellular Carcinoma Treatment

In consultation with the FDA, Bristol Myers Squibb has voluntarily withdrawn nivolumab (Opdivo®) as a single-agent treatment for patients with hepatocellular carcinoma (HCC) who had previously been treated with sorafenib. Nivolumab had previously been granted accelerated approval from the FDA in 2017, which was based on the phase 1/2 CheckMate 040 clinical trial (NCT01658878). The withdrawal of this treatment is due to the lack of statistical significance in the final overall survival results of...
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Nivolumab/Cabozantinib for Renal Cell Carcinoma: David Braun, MD, PhD, and Wenxin (Vincent) Xu, MD

Recently, the results of a phase 3 trial on nivolumab/cabozantinib were published in the New England Journal of Medicine. The study (CheckMate 9ER) compared the efficacy and safety of nivolumab/cabozantinib with those of sunitinib in adult patients with previously untreated advanced clear cell renal cell carcinoma (RCC). The trial results demonstrated that nivolumab/cabozantinib has significant benefits over sunitinib in this patient population. In this interview with Oncology Data Advisor, Dr. ...
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Nivolumab Effective for Relapsed Malignant Mesothelioma

In patients with relapsed malignant mesothelioma, nivolumab improves both overall and progression-free survival with a tolerable safety profile, according to results of the phase 3 CONFIRM trial recently presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. "Malignant mesothelioma is an intractable cancer," write the investigators, led by Dean Fennell, PhD, FRCP, Chair of Thoracic Medical Oncology at Leicester Cancer Research Centre in t...
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Advanced Renal Cell Carcinoma: Nivolumab/Cabozantinib Approved

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with cabozantinib (Cabometyx®, Exelixis) for patients with advanced renal cell carcinoma (RCC) receiving their first line of therapy. "As monotherapies, nivolumab and cabozantinib have demonstrated efficacy and a manageable safety profile in advanced RCC," wrote Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and colleagues in their abstract of results from the...
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Nivolumab/Ipilimumab for Malignant Pleural Mesothelioma: Paul Baas, MD, PhD

The FDA recently approved nivolumab/ipilimumab for the first-line treatment of malignant pleural mesothelioma, marking the second FDA approval for this condition and the first approval in the past 16 years. In this interview, Paul Baas, MD, PhD, principal investigator of the CheckMate 743 trial (NCT02899299), on which the approval was based, speaks with Oncology Data Advisor about the benefits and tolerability of nivolumab/ipilimumab, ongoing research advances in the treatment of malignant pleur...
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