AstraZeneca gains a speedy Imfinzi review in race to beat Roche on frontline SCLC
Well, Roche’s Tecentriq had a good few-month run as the lone frontline immunotherapy on the small-cell lung cancer market. That reign may soon end.
Over the holiday weekend, AstraZeneca announced its immuno-oncology drug Imfinzi has been granted an FDA ‘priority review’ for small-cell lung cancer, or SCLC. The designation comes on the heels of a 537-person trial showing the treatment helped patients live a little under 3 months longer than under the standard-of-care. A PDUFA date was set for the first quarter of 2020.
Although the most common type of lung cancer, non-small cell lung cancer or NSCLC, has been one of the most common targets for immunotherapies, SCLC has proven more elusive. In March, Roche’s Tecentriq became the first such therapy to get the FDA’s blessing as a frontline treatment (Opdivo and Keytruda have each been approved as a second-line therapy). Imfinzi, like Tecentriq, is a PD-L1 inhibitor.
The two drugs performed similarly on overall survival, the primary endpoint, in their respective Phase III trials. Tecentriq showed an OS of 12.3 months against a 10.3-month placebo arm, compared with Imfinzi’s 13 months against a 10.3-month placebo arm. AstraZeneca has also highlighted their drug’s durability of response. In both cases, patients also received standard chemotherapy.
For AstraZeneca, the new designation represents another step in a 2019 pipeline resurgence and a major win on a drug that flopped big last year.
That November, the British drugmaker said that after 5 years, its MYSTIC trial combining Imfinzi and a CTLA-4 inhibitor had failed. This August, they announced the combo had failed again. Nevertheless, new oncology chief José Baselga has seen approvals this year for the BTK inhibitor Calquence and positive readouts from trials testing an Imfinzi triple-mix in lung cancer and testing their PARP inhibitor Lynparza in ovarian and prostate cancers.
SCLC cases represent 10-15% of lung cancer cases, with NSCLC patients covering the rest. AstraZeneca has not announced the exact PDUFA date, but given the FDA’s recent breakneck pace in approvals, it may not matter.