At the beginning of November, the Food and Drug Administration approved Tremelimumab (an immunotherapy drug that helps the immune system to fight cancer cells) combined with Durvalumab (another immunotherapy drug) and chemotherapy, for the treatment of patients with metastatic non-small cell lung cancer who are not candidates for biological treatment and have not received prior systemic treatment*.

The approval was based on results from a clinical trial which evaluated Tremelimumab plus Durvalumab and chemotherapy versus chemotherapy alone, in first-line metastatic non-small-cell lung cancer.

The study enrolled 675 patients who were randomized to receive either Tremelimumab, Durvalumab and chemotherapy (study group), or chemotherapy alone (control group).

After a follow-up of about three years, results pointed towards a significant higher rate of disease response (tumor shrinkage) among patients in the study group who received Tremelimumab plus Durvalumab and chemotherapy, compared to those in the control group who received chemotherapy alone.

Moreover, a significantly lower death rate was observed among patients in the study group, compared to those in the control group.

Among the most common adverse events in patients receiving Tremelimumab, Durvalumab and chemotherapy were nausea, decreased appetite, diarrhea, musculoskeletal pain and rash.

Tremelimumab, Durvalumab and chemotherapy provides an efficient treatment option for patients with metastatic non-small cell lung cancer who have not received prior systemic therapy.

*A month ago, Tremelimumab combined with Durvalumab was approved also for the treatment of patients with unresectable hepatocellular carcinoma.