(Head and Neck Cancer) FDA Breakthrough Therapy Designation for Opdivo

Key highlights:

1. This information is from AACR (American Association for Cancer Research) on April 19, 2016, where Opdivo (nivolumab) received breakthrough therapy designation based on its efficacy.

2. Median overall survival was extended, and results showed efficacy in patients with PD-L1 or HPV infection.

3. This received FDA Breakthrough Therapy Designation.

At the American Association for Cancer Research (AACR) meeting held in the United States from April 16–20, the CheckMate-141 Phase III clinical trial of PD-1 antibody Opdivo (nivolumab) was presented for patients with head and neck squamous cell carcinoma (SCCHN) who had previously received platinum-based therapy.

Overall Survival: Opdivo's 1-year survival rate was approximately doubled compared to the control. The effect was even greater in patients with PD-L1 expression.

The clinical trial enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma (SCCHN): 240 received Opdivo and 121 received other treatments.

Based on these results, on April 25, the U.S. FDA designated Opdivo (anti-PD-1 antibody) as a Breakthrough Therapy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck who had previously received platinum-based treatment.

References:

• Nivolumab (nivo) vs investigator's choice (IC) for recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): CheckMate-141 (AACR2016, Abstract# CT099)
• Nivolumab Improved Survival For Patients With Head and Neck Squamous Cell Carcinoma (AACR News Release, April 19, 2016)
• Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) (ClinicalTrials.gov Identifier: NCT02105636)
• Ono Pharmaceutical and Bristol-Myers Squibb press release (April 21, 2016)
• Bristol-Myers Squibb's Opdivo (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (Bristol-Myers Squibb press release)

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