FDA Approves Opdivo for Advanced Head and Neck Cancer Patients

FDA Approves Opdivo for Advanced Head and Neck Cancer Patients

The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Opdivo (nivolumab) for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, whose disease progressed during or following platinum-based chemotherapy. The approval was based on results from the CheckMate 141 Phase 3 study (NCT02105636).

To date, patients with metastatic head and neck cancers whose disease failed to respond to platinum-based chemotherapy had no other therapeutic approaches to prolong survival. Opdivo may be a game-changer for such patients, with data from the clinical trial showing that it more than doubled patient survival rates, with fewer side effects, compared to options available currently.

The randomized, open-label, multicenter trial enrolled 361 patients with relapsed or metastatic head and neck cancer whose disease progressed during or within six months of platinum-based chemotherapy, and who were assigned randomly to receive either Opdivo (240 patients) or investigator’s choice chemotherapy. Chemotherapy treatments included Taxotere (docetaxel), Erbitux (cetuximab), or Rasuvo (methotrexate).

Data presented in October at the European Society for Medical Oncology (ESMO) Congress showed that Opdivo nearly doubled patients’ one-year overall survival rates from 17% in the chemotherapy group, to 36%.

Results also showed that Opdivo induced a statistically significant and clinical meaningful improvement in median overall survival compared to chemotherapy (7.5 months vs. 5.1 months), but that the benefit was even higher in patients with HPV-positive cancers (9.1 months vs. 4.4 months).

In addition, while patients receiving chemotherapy reported a deterioration in their physical, social, and emotional status, those in the Opdivo group remained stable.

Serious adverse reactions were seen in 49% of patients receiving Opdivo, with the most frequent serious adverse reactions including pneumonia, shortness of breath, respiratory failure, infection in the respiratory tract and sepsis.

The most common adverse reactions, seen in more than 10% of patients in the Opdivo group, were cough and shortness of breath, and the most common laboratory abnormalities included increased alkaline phosphatase, hypercalcemia, hyperalkalemia, increased amylase, and increased TSH.

Opdivo already was approved by the FDA to treat certain patients with metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, and Hodgkin lymphoma, either alone or in combination therapies. The FDA’s most recent approval further extends Opdivo’s indication to patients with head and neck cancers.

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