Dive Brief:
- Celcuity said Friday its experimental breast cancer drug succeeded in another part of an ongoing Phase 3 trial, positioning the company to seek broader approval of a treatment that’s already undergoing a regulatory review.
- According to Celcuity, two- and three-drug combinations involving its therapy gedatolisib helped delay disease progression compared to a regimen with Novartis’ targeted medication Piqray and hormone therapy. Celcuity tested those combinations in people whose tumors were driven by a mutation in the PIK3CA gene and said, without specifics, that treatment was associated with a “statistically significant and clinically meaningful improvement.” The results will be featured at the upcoming American Society of Clinical Oncology meeting, which begins on May 29.
- Celcuity previously reported that gedatolisib appeared to help breast cancer patients without confirmed PIK3CA mutations. The company has already filed for U.S. approval, and a decision is expected by July 17. Celcuity intends to submit the new data in a supplemental application that could expand use to include people with those mutations. Shares climbed more than 18% on Monday, pushing Celcuity’s market value past $7 billion.
Dive Insight:
PIK3CA alterations are involved in a wide variety of cancers and, notably, an estimated 40% of people with a breast tumor that’s hormone receptor positive, but negative for the protein HER2. That’s made them an increasingly popular target among drugmakers looking for medicines that can block their activity.
A few treatments, such as Piqray, Roche’s Itovebi and AstraZeneca’s Truqap, are already available. But all are associated with side effects, such as skin rashes, gastrointestinal issues and hyperglycemia, that can hinder uptake.
Celcuity is among several companies looking to bring to market better treatments that are either more selective or potent. It’s already close to an approval, following Phase 3 data last July that showed gedatolisib combinations significantly delayed disease progression compared to two other established drug regimens.
But investors and analysts have been watching for additional results from that same trial that specifically included people with confirmed PIK3CA mutations. A meaningful improvement in that cohort could yield a broader market opportunity for Celcuity and help the drug separate itself from other therapies.
Heading into the data readout, analysts generally expected positive findings. But the fact that the two-drug combination including gedatolisib hit statistical significance is “particularly notable,” wrote Jefferies analyst Maury Raycroft. The finding suggests at least a two- to three-month separation from the control arm, he predicted.
The newly disclosed inclusion of Celcuity’s data at ASCO also “bodes well for the magnitude of benefit” associated with treatment, wrote Leerink Partners analyst Andrew Berens. Presentations were first announced last month, suggesting ASCO may have let Celcuity submit its results after the deadline, he added.
The meeting will be held from May 29 to June 2 in Chicago.
