AstraZeneca said it is ending a late-stage trial that combined one of its key experimental drugs with chemotherapy to treat a certain type of lung cancer, extending a run of setbacks that has deepened scrutiny of the drugmaker’s development pipeline.
Investor confidence in the British drugmaker 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.
The latest decision followed a recommendation from an independent data monitoring committee, which found AstraZeneca’s volrustomig drug, when combined with chemotherapy, was unlikely to help patients live longer or keep their disease from worsening compared with rival Merck’s blockbuster immunotherapy Keytruda plus chemotherapy.
SHARES UP AFTER POSITIVE FINDINGS ELSEWHERE
Separately, however, AstraZeneca 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 more than 16% of their value this year, by nearly 1%.
The discontinued trial, which accounted for about 20% of the drug’s peak sales estimate, does not impact the company’s $80 billion sales ambition by 2030, a company spokesperson said.
AstraZeneca had previously predicted more than $5 billion in peak sales from volrustomig.
MORE IMPORTANT DATA
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.
Other Phase III trials of the drug in treating cervical cancer, head and neck squamous cell carcinoma and mesothelioma will continue as planned, the company said.
Shares in AstraZeneca also took a hit earlier this month after media reports of merger talks with U.S. rival Bristol Myers Squibb BMY.N.
Markus Manns, portfolio manager at Union Investment, an AstraZeneca shareholder, said the mixed readouts were “incremental” to AstraZeneca’s investment story, as all three studies were in small indications.
“Upcoming Avanzar and Serena-4 data are far more important and the market has still to fully digest the implications from the recent Astra-Bristol rumours,” he added.
COMPANY TARGETS 20 NEW DRUG LAUNCHES
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 company, which also in July 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.