According to Persistence Market Research, the global bladder cancer treatment drugs market reached a size of $2bn in 2021 and is estimated to surge to $11.5bn by 2032, advancing at a 17% CAGR from 2022 to 2032.
Two companies targeting high-risk non-muscle invasive bladder cancer (NMIBC) are nearing approval of drugs that show great promise.
ImmunityBio‘s drug is Anktiva (N-803) + BCG for the treatment of patients with BCG-unresponsive Carcinoma In Situ (CIS) NMIBC. Bacillus Calmette-Guerin (BCG) is the current standard of care for NMIBC. Phase 3 trials are complete, with promising results.
CG Oncology‘s candidate cretostimogene (CG0070) is initially in development for the treatment of patients with NMIBC who are unresponsive to BCG therapy. The company is evaluating CG0070 as a monotherapy in BOND-003, its ongoing Phase 3 trial in high-risk BCG-unresponsive NMIBC patients, and expects to report top-line data by the end of 2024. There is a Phase 2 combination therapy showing promising results too.
Here is a comparison of the two:
Both CG0070 and N-803 + BCG are promising new treatment options for NMIBC, particularly for patients unresponsive to standard BCG therapy. However, they differ in several key aspects:
Type of therapy
CG0070: Oncolytic immunotherapy – uses a modified virus to infect and kill cancer cells, stimulating an immune response.
N-803 + BCG: Combination immunotherapy – N-803 is an IL-15 superagonist that boosts the immune system, while BCG acts as a prime to activate immune cells.
Target patients
CG0070: Primarily for high-risk, BCG-unresponsive NMIBC.
N-803 + BCG: BCG-unresponsive NMIBC, but may have broader potential in the future.
Clinical results
CG0070: Promising Phase 2 results with monotherapy, showing an overall CR rate of 75.7% in BCG-unresponsive NMIBC. Even more promising early data from Phase 2 combination therapy with pembrolizumab, with an 88% CR rate at 3 months. Phase 3 trials ongoing for full safety and efficacy evaluation.
N-803 + BCG:Phase 2/3 QUILT 3.032 trial showed a CR rate of 71% in patients with carcinoma in situ. FDA initially declined the BLA due to manufacturing deficiencies, but the company resubmitted and is awaiting a decision.
Current stage of development
CG0070: Fast Track and Breakthrough Therapy designations from the FDA.
N-803 + BCG: Phase 3 complete. Awaiting FDA approval after resubmission of the BLA.
Potential advantages
CG0070: Stronger early data, especially the combination therapy results. May be easier to administer as a single agent.
N-803 + BCG: May have broader potential beyond BCG-unresponsive NMIBC due to the combination approach. Plus, N-803 potentially targets multiple immune pathways for a more robust response.
Potential drawbacks
CG0070: Requires further data from ongoing Phase 3 trials for definitive conclusions. May have some off-target effects due to the viral vector delivery.
N-803 + BCG: Delayed market availability due to the ongoing regulatory process. More complex treatment regimen involving both N-803 and BCG.
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