On April 16, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported two-year overall survival (OS) data from CheckMate -141, a Phase 3 open-label, randomized trial evaluating Opdivo (nivolumab) compared with investigator’s choice chemotherapy (cetuximab, docetaxel or methotrexate) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after failure on platinum-based therapy (Press release, Bristol-Myers Squibb, APR 16, 2018, View Source [SID1234525334]). Patients treated with Opdivo experienced a 32% reduction in the risk of death after a minimum two years of follow-up (HR 0.68; 95% CI: 0.54 to 0.86), with a median OS of 7.7 months (95% CI: 5.7 to 8.8) compared with 5.1 months (95% CI: 4.0 to 6.2) for standard chemotherapy. The two-year survival rate for Opdivo was 16.9% (95% CI: 12.4 to 22.0) versus 6.0% (95% CI: 2.7 to 11.3) for standard chemotherapy. The safety profile for Opdivo at two-year follow-up was consistent with previous analyses from the study.
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These data will be presented today as an oral presentation (Abstract #CT116) at 4:35 PM CDT, N Hall C (Level 1) during the Updates in Immuno-Oncology Trials session at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago.
"The introduction of Immuno-Oncology has the potential to change the treatment landscape of squamous cell carcinoma of the head and neck, compared with the standard of care," said Robert L. Ferris, M.D., Ph.D., a cancer immunotherapist and Director, UPMC Hillman Cancer Center, Pittsburgh, PA. "The sustained overall survival benefit demonstrated by nivolumab in this study is encouraging in SCCHN, which historically has a median survival of less than six months."
The sustained Opdivo OS benefit was observed across PD-L1 expressors and non-expressors in patients with recurrent or metastatic SCCHN. At the two-year follow-up in patients treated with Opdivo whose tumors had PD-L1 expression ≥ 1%, risk of death was reduced by 45% (HR 0.55; 95% CI: 0.39 to 0.78). For patients treated with Opdivo whose tumors had PD-L1 expression <1%, risk of death at two years was reduced by 27% (HR 0.73; 95% CI: 0.49 to 1.09) versus standard chemotherapy.
"Opdivo is the only I-O treatment for squamous cell carcinoma of the head and neck to have shown a significant overall survival benefit versus chemotherapy at the primary analysis. These two-year follow-up data show a sustained long-term overall survival benefit for patients, across PD-L1 expression levels and regardless of HPV status," said Shinta Cheng, M.D., Ph.D., development lead, Bristol-Myers Squibb. "These data showing the durability of this benefit reinforce our ongoing commitment to continuing research with the hope of delivering what matters most to patients fighting cancer: long-term survival."
There were no statistically significant differences between the two arms for PFS (HR 0.87; 95% CI: 0.68 to 1.11) for Opdivo and investigator’s choice, respectively. The safety profile of Opdivo with a two-year follow-up was consistent with previous analyses and with prior studies of Opdivo in patients with melanoma and non-small cell lung cancer. Grade 3-4 treatment-related adverse reactions occurred in 15.3% of patients receiving Opdivo versus 36.9% of patients receiving investigator’s choice.
About CheckMate -141 (Abstract #CT116)
CheckMate -141 is a global phase 3, open-label, randomized trial evaluating Opdivo versus investigator’s choice chemotherapy in patients with recurrent or metastatic SCCHN who had tumor progression during or within six months of receiving platinum-based therapy administered in the adjuvant, neo-adjuvant, primary (unresectable locally advanced) or metastatic setting. Patients were included regardless of their HPV or PD-L1 status. Patients were randomized 2:1 to receive Opdivo 3 mg/kg intravenously over 60 minutes every two weeks (n=240), or investigator’s choice (n=121) of methotrexate 40 to 60 mg/m2 intravenously weekly, docetaxel 30 to 40 mg/m2 intravenously weekly, or cetuximab 400 mg/m2 intravenously once then 250 mg/m2 weekly. The primary endpoint is OS. The trial’s secondary endpoints include progression-free survival (PFS) and objective response rate (ORR).
About Head & Neck Cancer
Cancers that are known as head and neck cancers usually begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, such as inside the mouth, the nose and the throat. Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease. Squamous cell carcinoma of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers, with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption. The human papillomavirus (HPV) infection is also a risk factor leading to rapid increase in oropharyngeal SCCHN in Europe and North America. Quality of life is often impacted for SCCHN patients, as physiological function (breathing, swallowing, eating, drinking), personal characteristics (appearance, speaking, voice), sensory function (smell and hearing), and psychological/social function can be affected.