AstraZeneca NYSE:AZN, a global pharmaceutical company focused on oncology and other major therapeutic areas, could gain a potential new cancer treatment with estimated peak sales between $3 billion and $5 billion after a late-stage study produced positive topline results. Sonesitatug vedotin is being evaluated for patients with advanced or metastatic gastric cancer. The drug is being developed by KYM Biosciences, a joint venture between Keymed Biosciences, a Hong Kong-listed biotechnology company, and Lepu Biopharma, a Chinese biopharmaceutical company, in collaboration with AstraZeneca.
Keymed said the treatment produced a clinically meaningful improvement in overall survival compared with standard chemotherapy during the global Phase III trial. The study achieved its primary overall-survival endpoint among patients receiving third-line or later treatment. It also met a key secondary overall-survival endpoint across patients receiving second-line or later treatment. However, the drug did not produce a statistically significant result for its other primary endpoint of progression-free survival, although Lepu reported an improving trend.
Keymed and Lepu said the treatment was well tolerated and produced no new safety concerns during the study. Based on the positive results, AstraZeneca estimated that the drug could eventually generate peak annual sales between $3 billion and $5 billion. The $2 billion difference between the lower and upper estimates reflects considerable uncertainty around adoption, regulatory approvals and the patient populations that may ultimately qualify for treatment. Investors may view the overall-survival result as supportive of AstraZeneca's oncology pipeline, but the progression-free-survival outcome and future regulatory reviews could remain important factors before the commercial opportunity becomes clearer.