AstraZeneca’s Imfinzi alone and in combination fails in Stage IV lung cancer trial

AstraZeneca has announced its Phase III MYSTIC trial of Imfinzi alone and Imfinzi combined with tremelimumab in untreated non-small cell lung cancer (NSCLC) patients failed to meet its primary endpoint.

Overall survival results compared to standard of care platinum-based chemotherapy were not statistically significant and the hazard ratio for both drugs were high; 0.76 for monotherapy and 0.85 for combination therapy.

The safety and tolerability of Imfinzi alone and Imfinzi with tremelimumab was similar to previous trials.

AstraZeneca executive vice-president of global medicines eevelopment and chief medical officer Sean Bohen said: "We are disappointed that these results missed statistical significance. We remain confident in Imfinzi as the cornerstone of our immunoncology programme and continue to evaluate its potential in ongoing non-small cell lung cancer trials, including Imfinzi and Imfinzi plus tremelimumab in combination with chemotherapy."

Imfinzi is a human monoclonal antibody which binds to programmed death-ligand 1 (PD-L1) and blocks PD-L1’s interaction with CD80 countering tumour’s immune-evading tactics.

The drug was approved for unresectable Stage III NSCLC by the FDA in February this year based upon the PACIFIC clinical trial; it is currently approved in forty countries globally.

AstraZeneca head of the oncology business unit Dave Fredrickson said: "The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy.

"Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting."

The drug is also approved for locally-advanced or metastatic urothelial cancer.

Tremelimumab is an anti-CTLA4 antibody blocks activity of CTLA4 and contribute to T-cell activation.

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