RE:Dr. Black article on Phase 2 Trial of Atezolizumab DJDAWG ... Nice constructive post. Thanks for providing the competition efficacy results. It allows a global perspective on where we stand. And confirms we're top of the class.
I think one major efficacy data is missing though (the one from the recently approved (Dec. 2022 Ferring's gene therapy), so here it is:
The complete response rate was 51%, the median duration of response was 9.7 months, and 46% of responding patients remained in complete response for at least one year.
Patients received nadofaragene firadenovec-vncg 75 mL intravesical instillation (3 x 1011 viral particles/mL) once every three months up to 12 months, unacceptable toxicity, or recurrent high-grade non-muscle invasive bladder cancer
Note also this limitation from the FDA, that TLT doesn't have:
Individuals who are immunosuppressed, or immune-deficient should not come into contact with Adstiladrin.
Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-high-risk-non-muscle-invasive-bladder-cancer
In granting the approval, the FDA cited data showing more than half of patients who received the drug achieved a complete response. The drug is given every three months into the bladder via a urinary catheter.
Adstiladrin offers patients a new treatment in a cancer setting where few effective options exist. Historically, patients who developed BCG-unresponsive disease would undergo bladder removal surgery, Ferring Chief Science Officer Armin Metzger, Ph.D., said in an interview.
Despite the Ferring drug’s solid data, it wasn't exactly a smooth path to the FDA nod. In May 2020, the FDA rejected the drug, citing outstanding questions for the company’s manufacturing partner.
Since then, Ferring has been working with its partner and the FDA to bring the production process in line with the agency’s expectations, Metzger said. As with other gene therapies, Adstiladrin has a “very complicated, very long, very product-tailored" production process, he noted.
The company is working with a Finnish manufacturing partner called FinVector. At the same time, Ferring is also working to grow its own capacity, Metzger said.
Ferring previously spun off the drug into a separate company called FerGene. But Ferring later reassumed control of the gene therapy when FerGene wound down its operations.
Source: https://www.fiercepharma.com/pharma/after-2020-rejection-ferring-finally-nabs-fda-nod-bladder-cancer-gene-therapy#:~:text=On%20Friday%2C%20the%20FDA%20approved,with%20or%20without%20papillary%20tumors.
Interesting also to see that TLD1433 (Ruvidar) has a longer shelf stability. See Adstiladrin's one under the "Dating period" section below, on page 2. It has only a 18 months period when stored at -60 dregrees Celsius and only 3 months at room temperature (versus 3y+ for TLD1433 at room temperature). So Ferring's gene therapy will cost way more because of more waste and more complex manufacturing process.
Note also the "Advisory Committee" section on p. 2 and you'll understand that TLT won't have to go through such process given the lack of issues.
https://www.fda.gov/media/164030/download?attachment