AstraZeneca PLC AstraZeneca (AZN) dropped some encouraging news Thursday from its Phase 3 VOLGA trial, and it's a big deal for a specific group of bladder cancer patients: those who can't take cisplatin-based chemotherapy.
The trial tested a perioperative regimen of Imfinzi (durvalumab) plus neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who either couldn't tolerate cisplatin or chose not to take it. The combo delivered statistically significant and clinically meaningful improvements in both event-free survival and overall survival compared to standard treatment—which, for these patients, is typically just surgery (radical cystectomy) with or without approved adjuvant therapy.
That's a meaningful advance. Muscle-invasive bladder cancer makes up about a quarter of all bladder cancer cases, and up to half of those patients can't receive cisplatin because of kidney problems or other health issues. For them, surgery has been the main option, even though recurrence rates are high. Having a drug combination that improves survival before and after surgery could change the treatment landscape.
Imfinzi-Imjudo Combo: Good, But Not Quite There Yet
The trial also had a second arm that added Imjudo (tremelimumab) to the mix. That three-drug combo also showed a statistically significant improvement in event-free survival. But when it came to overall survival, the data showed a favorable trend but didn't reach statistical significance in this planned interim analysis. AstraZeneca said it will reassess that endpoint in a future analysis.
So the Imfinzi-plus-enfortumab-vedotin combo is the clear winner here, at least for now. The safety profile for both regimens was consistent with what's already known about these drugs, with no new safety signals.
What's Next
AstraZeneca plans to present the full data at a future medical meeting and submit the results to global regulators. That's the next step toward potentially expanding Imfinzi's already broad label.
Imfinzi is already approved in more than 40 countries for cisplatin-eligible muscle-invasive bladder cancer, based on the Phase 3 NIAGARA trial. And it's under review in several markets for high-risk non-muscle-invasive bladder cancer, following the POTOMAC trial. This new data could open up treatment for the large group of patients who've been left out of that earlier approval.
AZN Price Action: AstraZeneca shares were down 1.16% at $185.54 at the time of publication Thursday. Over the past month, AZN has declined about 8.4% versus an 8.7% rise in the S&P 500, and is roughly flat year-to-date compared to the index's 9.1% gain.
