AstraZeneca's Experimental Cancer Drug Misses Target in Pivotal Trial — Update

By Christian Moess Laursen

AstraZeneca's cancer drug, datopotamab deruxtecan, failed to meet targets in a Phase 3 trial, clouding the possibility of approval from the U.S. Food and Drug Administration.

Shares were down 1.2% at 116.52 pounds in early morning trading in Europe, paring back the year-to-date gain to 9.9%.

The Anglo-Swedish pharmaceutical giant said Monday that the experimental drug was tested on more than 700 breast cancer patients with inoperable or metastatic hormone receptor-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

Results from the Phase 3 trial failed to show a statistical significance in the final overall-survival analysis for patients compared to the current standard of care, chemotherapy, AstraZeneca said.

In a Phase 3 trial, researchers find out if a drug offers benefits to a specific group of patients within a broader category of a disease. It is the last trial phase before companies can request regulatory approval to market a drug.

Today's disappointing trial result puts approval from the U.S. FDA in jeopardy, Shore Capital analyst Sean Conroy said in a note.

"In the absence of a clear overall-survival benefit, we believe that approval now looks less likely," Conroy wrote. Shore Capital expects a decision from FDA during the first half of 2025.

Executive Vice President Susan Galbraith said that the result is still of clinical value and will be shared with regulatory authorities.

Earlier this month, datopotamab deruxtecan--also called Dato-DXd--similarly missed its target in a Phase 3 lung-cancer trial, causing AstraZeneca shares to drop more than 5%.

The antibody drug conjugate was discovered by Japanese pharmaceutical company Daiichi Sankyo and is being jointly developed by AstraZeneca and Daiichi Sankyo.

The two companies are currently evaluating the drug alone and with immunotherapy as treatment for patients with triple-negative or HR-low, HER2-negative breast cancers.

Last year, the treatment met targets in a trial testing its progression-free survival in non-small cell lung cancer patients.

Write to Christian Moess Laursen at christian.moess@wsj.com

(END) Dow Jones Newswires

September 23, 2024 04:13 ET (08:13 GMT)

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