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AZ’s immuno-oncology combo fails another lung cancer trial

Latest failure casts doubt on company’s CTLA4 drug


Shares in AstraZeneca were on the slide this morning after its combination of Imfinzi and tremelimumab failed to hit the mark in a phase III lung cancer trial.

The company said the duo was unable to outperform chemotherapy on either progression-free survival or overall survival when used as a third-line treatment for patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) in the ARCTIC trial.

Looking for the silver lining, AZ it was encouraged by the performance of PD-L1 inhibitor Imfinzi (durvalumab) as a monotherapy in a subgroup of patients in the trial, saying it achieved a “clinically meaningful reduction in the risk of death compared to chemotherapy”, although the trial wasn’t powered to detect statistical significance.

There is no doubt, however, that the study raises another question mark over the role of CTLA4 inhibitor tremelimumab. It is being studied alongside Imfinzi in a number of indications including bladder, head and neck, liver and haematological cancers.

Imfinzi picked up a valuable approval from the FDA in February as a monotherapy maintenance therapy for NSCLC patients with inoperable stage III disease, i.e. which has not spread widely around the body after platinum chemotherapy or radiotherapy, but AZ’s ambitions for the drug have been undermined in other areas.

An attempt to muscle into the first-line NSCLC setting – currently dominated by Merck & Co’s Keytruda was held back by the failure of the Imfinzi and tremelimumab combination to improve PFS in the MYSTIC trial. AZ is still waiting for the read-out from the trial on OS, which was pushed back to the second half of this year last month, but the latest data will only reduce hopes of a positive outcome.

The news is particularly disappointing given that Bristol-Myers Squibb’s combination of PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab) met its objectives in first-line NSCLC, besting chemotherapy on PFS.

There was better news for AZ in cancer last week, after the company picked up FDA approval for its EGFR inhibitor Tagrisso (osimertinib) as a first-line treatment for patients with EGFR-mutated NSCLC.

Tagrisso was already approved as a second-line therapy in this setting, but a green light in previously-untreated patients is seen as key to unlocking its sales potential, which AZ has suggested suggest could be as high as $3bn a year at peak.

New data from the FLAURA trial, which supported the front-line approval, were presented last week and showed that the median time to first subsequent therapy or death was 23.5 months for patients treated with Tagrisso, compared to 13.8 months for those on Roche’s Tarceva (erlotinib) or AZ’s earlier-generation EGFR drug Iressa (gefitinib).

Article by
Phil Taylor

24th April 2018

From: Research



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