CG Reports New Bladder Cancer Drug Results After Major IPO

CG Oncology has reported promising Phase 3 trial results for its experimental drug, cretostimogene, which shows significant efficacy in treating non-muscle invasive bladder cancer. The drug has driven cancer into remission in approximately 75% of the trial participants. Earlier, the company revealed that 50 of 66 patients had no detectable disease post-treatment. Recent data updates that 79 out of 105 patients achieved complete responses, and 29 of 35 participants monitored for at least a year remain cancer-free, although 22 participants are still pending further evaluation.

Cretostimogene's common side effects include bladder spasms, frequent urination, and hematuria, with two serious adverse events reported as clotting or inflammation in the bladder. Despite these side effects, no participants discontinued the treatment. CG Oncology plans to present the final study results later this year and may seek regulatory approval based on those outcomes.

Non-muscle invasive bladder cancer is usually treated with BCG immunotherapy after tumor resection. However, BCG is not effective for all patients, and about half of those who do respond experience cancer recurrence. This leaves limited options such as chemotherapy or surgical removal of the bladder. CG Oncology's cretostimogene, an oncolytic virus-based immunotherapy, aims to provide a new treatment option. The company is also testing the drug in combination with Merck's Keytruda in an ongoing Phase 2 trial, with results expected at the upcoming American Society of Clinical Oncology meeting.

Competition in this field is strong, with recent FDA approvals for Keytruda, a gene therapy from Ferring Pharmaceuticals, and an immunotherapy by ImmunityBio. A Johnson & Johnson device that delivers chemotherapy directly into the bladder is also showing promise in trials. Results from these studies were expected to be presented at a medical conference.

Despite the competition, CG Oncology has garnered substantial support from Wall Street analysts and investors. In January, the company raised $380 million in the largest initial public offering of the sector this year. According to Cantor Fitzgerald analyst Josh Schimmer, the offering was one of the highest-demand investment opportunities, citing the company’s robust study results, development plans, and cretostimogene’s potential long-term market exclusivity. Schimmer believes that if approved, the drug could generate over $1 billion in annual peak sales.

The recent Phase 3 trial, BOND-003, evaluates cretostimogene as a monotherapy in patients who have not responded to BCG therapy and are at high risk of cancer recurrence. CG Oncology has assessed 105 out of 112 participants for efficacy, making it the largest dataset ever reported in this specific treatment area. The complete response rate has maintained around 75%, even as more patients were enrolled. Importantly, over 92% of patients did not require bladder removal, and none of the participants who achieved a complete response underwent the procedure. The company plans to continue monitoring bladder removal rates.

CG Oncology's CEO Arthur Kwan highlighted the significance of avoiding bladder removal for many patients, which is why the FDA is particularly interested in this population. While acknowledging the competitive landscape and the potential for data shifts as more scans are performed, Kwan noted that cretostimogene's complete response rates appear higher than those observed in trials of therapies from Merck, Ferring, and ImmunityBio. The company is also exploring the drug's effectiveness earlier in the disease course, particularly in patients with an intermediate risk of recurrence.

"This is just the beginning," Kwan stated, emphasizing the potential future applications of cretostimogene in treating bladder cancer.