AstraZeneca AZN.L is discontinuing a late-stage trial that tested experimental drug volrustomig plus chemotherapy in patients with metastatic non-small cell lung cancer, it said on Monday, extending a run of setbacks that has deepened scrutiny of the drugmaker's development pipeline.
The decision followed a recommendation from an independent data monitoring committee, which found the volrustomig combination was unlikely to meet either of its primary endpoints of progression-free survival or overall survival in patients whose tumours lacked the PD-L1 protein.
Pipeline pressure and company outlook
Investor confidence has been dented by a series of blows, including the surprise failure of Wainua in a late-stage heart disease trial, the rejection of breast cancer drug camizestrant by a U.S. regulatory panel on trial design grounds, and a late-stage failure for rare disease drug Ultomiris.
AstraZeneca's shares also took a hit earlier this month after media reports of merger talks with U.S. rival Bristol Myers Squibb BMY.N.
AstraZeneca stood by its forecasts in July, including its target of $80 billion in annual revenue by 2030, expressing confidence that the recent setbacks had not undermined its long-term prospects.
The drugmaker, which topped second-quarter profit expectations on strong demand for its cancer and rare disease therapies, is counting on up to 20 new drug launches to help reach that target.
"While we are disappointed, we will learn from this trial," said Susan Galbraith, AstraZeneca's executive vice president for oncology haematology R&D.
The company said the safety profile of volrustomig in combination with chemotherapy was consistent with the known profiles of the individual medicines, with no new safety signals identified.
Volrustomig is a dual checkpoint inhibitor bispecific antibody designed to unblock two key immune pathways, PD-1 and CTLA-4, to help the immune system attack tumours.
Other volrustomig trials will continue
Other Phase III trials of volrustomig in cervical cancer, head and neck squamous cell carcinoma and mesothelioma will continue as planned, the company said.
Other late-stage lung cancer readouts were positive
Separately, however, the company reported positive readouts from two other late-stage lung cancer trials, with its Tagrisso-Orpathys combination and the Daiichi Sankyo-partnered Enhertu both meeting key goals.
That helped lift AstraZeneca's shares, which have shed over 16% of their value this year, by about 1% at 0939 GMT.
Volrustomig was projected to generate about $750 million in peak annual sales for metastatic non-small cell lung cancer, Citi analyst Graham Parry said in a note. The loss from the discontinued trial could potentially be offset by ongoing Phase III trials for volrustomig in other indications, Parry said.
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