On June 4, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection (Press release, Bristol-Myers Squibb, JUN 4, 2018, View Source [SID1234527123]). In updated results from the study, Opdivo continued to demonstrate statistically longer recurrence-free survival (RFS) of 62.6%, the primary endpoint of the study, versus 50.2% for Yervoy (HR: 0.66, P<0.0001) at a minimum follow-up of 24 months across key subgroups, including disease stages and BRAF mutation status.

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No new safety data were generated as part of the 24-month analysis. As previously reported from the 18-month analysis, Opdivo demonstrated a significantly lower rate of adverse events (AEs) leading to discontinuation (9.7% of patients in the Opdivo arm compared to 42.6% of patients in the Yervoy arm) and treatment-related grade 3/4 AEs (14.4% of patients in the Opdivo arm compared to 45.9% in the Yervoy arm).

Findings will be presented on Monday, June 4 from 8:24-8:36 AM CDT during the Melanoma/Skin Cancers session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2018 in Chicago (Abstract #9502).

"The broader use of Immuno-Oncology agents has changed the cancer treatment landscape and, with advances in research, we have been able to extend the use of these agents to adjuvant therapy in melanoma in order to help prevent disease recurrence," noted Jeffrey S. Weber, M.D., Ph.D., principal investigator of CheckMate -238. "Results from the study’s 24-month follow-up, the longest follow-up of any PD-1 inhibitor in the adjuvant setting, continue to strongly support the benefit of nivolumab across multiple stages of melanoma and BRAF mutation status."

Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb, said, "The updated CheckMate -238 data continue to show that adjuvant treatment can change the course of melanoma by preventing relapse and progression to an advanced stage."

Additional Data from CheckMate -238 at ASCO (Free ASCO Whitepaper) 2018

In the study, Opdivo demonstrated superior RFS versus Yervoy, regardless of disease stage, PD-L1 expression or BRAF mutation status, with RFS rates of 62.6% with Opdivo compared to 50.2% with Yervoy in the intent-to-treat patient population. In patients with stage IIIB melanoma, RFS rates at 24 months for Opdivo were 70.8% versus 60.7% with Yervoy; for patients with stage IIIC melanoma, RFS rates were 58.0% with Opdivo versus 45.4% with Yervoy; and for patients with stage IV melanoma, RFS rates for Opdivo were 58.0% versus 44.3% with Yervoy. In patients with BRAF mutant melanoma, RFS rates for Opdivo were 61.9% versus 51.7% with Yervoy; in patients with BRAF wild-type melanoma, Opdivo demonstrated a RFS of 63.5% versus 46.2% with Yervoy.

About CheckMate -238

CheckMate -238 is an ongoing Phase 3, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma. The trial randomized 906 patients 1:1 to receive either Opdivo 3 mg/kg every two weeks (n=453) or Yervoy 10 mg/kg (n=453) every three weeks for four doses and then every 12 weeks starting at week 24. Patients were treated until disease recurrence, unacceptable toxicity or withdrawal of consent for up to one year. The primary endpoint is RFS, defined as the time between randomization and the date of first recurrence, new primary melanoma or death. After meeting the primary endpoint, the trial will continue to evaluate for overall survival, a secondary endpoint.

Adjuvant Therapy in Melanoma

Melanoma is separated into five staging categories (stages 0 to 4) based on the in-situ feature, thickness and ulceration of the tumor, whether the cancer has spread to the lymph nodes, and how far the cancer has spread beyond lymph nodes.

Stage III melanoma has reached the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized), and requires surgical resection of the primary tumor as well as the involved lymph nodes. Some patients may also be treated with adjuvant therapy. Despite surgical intervention and possible adjuvant treatment, most patients experience disease recurrence and progress to metastatic disease. By five years, the majority of stage IIIB and IIIC patients (68% and 89%, respectively) experience disease recurrence.