Cretostimogene Grenadenorepvec

FRIDAY, Dec. 6, 2024 -- There's new hope for people battling advanced bladder cancer who do not respond to first-line therapy, researchers report. An experimental new drug with the unwieldy name of cretostimogene grenadenorepvec spurred complete remission of the cancer in three-quarters of patients who hadn't responded to an immune-focused treatment typically used to fight the disease. "These findings address a significant unmet need for bladder cancer patients and could improve their quality of life," said lead researcher Dr. Mark Tyson , a urologic oncologist at the Mayo Clinic Comprehensive Cancer Center in Rochester, Minn. His team presented its findings Thursday in Dallas at the annual meeting of the Society of Urologic Oncology. According to the American Cancer Society , over 83,000 new cases of bladder cancer are diagnosed among Americans each year, with almost 17,000 deaths linked to the disease. The cancer typically strikes older people and men are at higher risk than women. As the researchers explained, first-line therapy for bladder cancer typically involves a therapeutic vaccine called Bacillus Calmette-Guérin (BCG). BCG was developed as far back as 1921, and it's also used to fight tuberculosis. But cancer doctors realized that BCG could set up an immune response in the bladder that drew immune cells to the organ, where they could battle cancer cells. However, not every patient responds to BCG therapy, Tyson and crew noted. The new study enrolled 110 patients who had failed BCG therapy. They received intermittent doses of cretostimogene grenadenorepvec within the bladder over a period of three years. According to a news release from Mayo, "nearly 75% experienced complete cancer remission, with many remaining cancer-free beyond two years." The clinic went on to add that "most participants did not require bladder removal surgery, and the treatment was well tolerated with minimal serious side effects." The researchers plan more trials to see if the new treatment works over the longer term, and whether combining it with other therapies might boost benefits even further. "We now know this treatment can be both effective and safe, potentially reducing the need for bladder removal surgery and providing a much-needed alternative for patients with limited options," Tyson said. Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

CG Oncology says its immunotherapy candidate that could help patients avoid surgery may deliver lasting responses in a certain form of bladder cancer based on late-stage trial data. The California biotech’s oncolytic virus therapy, named cretostimogene grenadenorepvec, has not yet reached median duration of response in a Phase 3 study in people with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to the Bacillus Calmette-Guérin vaccine, which is usually part of a first-line regimen. That said, the median DOR exceeded 27 months at the Sept. 30 data cutoff, according to data presented Thursday at the Society of Urologic Oncology annual meeting in Dallas. For context, Merck’s Keytruda, which is often used in the second line, has a median DOR of around 16 months, CG Oncology CEO Arthur Kuan told Endpoints News in an interview. CG also reported that 97.3% of patients did not progress to muscle-invasive disease at 12 months. Also, just over half of the enrolled patients remained responsive to treatment at 24 months or more based on Kaplan-Meier estimations. Thursday’s durability data add to an interim readout in May that showed the asset cleared tumors in 75% of the 112 patients in the trial. The latest safety results were also consistent with the May data, with no reports of grade 3 or higher adverse events or treatment-related discontinuation. The most common side effects included bladder spasm, frequent urination and urgent urination. Cretostimogene “basically spares normal cells” because they don’t harbor RB/E2F1 mutations, Kuan said. Cretostimogene has the potential to become a “backbone bladder-sparing therapeutic” if it secures US approval, CG’s chief operating officer Ambaw Bellete said in a company release. Most patients in the Phase 3 did not have surgery to remove all or part of their bladder before joining the study. The biotech plans to file the treatment with the FDA in the second half of 2025. CG went public via a $380 million upsized listing on the Nasdaq in January. The company plans to launch cretostimogene alone in most markets, although it has a partnership with Kissei Pharmaceutical for Japan, South Korea, Taiwan and a number of other Asian countries except China. It had $540.7 million in cash and equivalents at the end of September, which should support it through 2027. Elsewhere, the biotech is also testing the treatment in the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC. Market competition for NMIBC is steadily growing after the FDA greenlit ImmunityBio’s Anktiva plus BCG for a subgroup of patients in April. Johnson & Johnson is advancing a drug-device combination that it calls the “pretzel” for people with high- and intermediate-risk NMIBC.