The list includes what I am aware of and includes the treatment and diagnosis which had been approved by FDA
For Non-muscle invasive bladder cancers
Most notable developments are for BCG Unresponsive. I think it is because BCG is still considered the best first line treatment for high risk non-muscle invasive bladder cancer.
1. NK cells immunotherapy by ImmunityBio. BCG plus Interleukin-15 based NK cells primer, which activates inactive NK cells near cancer cells. Preliminary data from Phase 2/3 clinical trial shows better efficacy than Pembrolizumab (Keytruda) which had been approved in January 2020 for BCG unresponsive. NK cells immunotherapy + BCG are administered into bladder.
www.businesswire.com/news/home/20220523005627/en/ImmunityBio-Submits-Biologics-License-Application-for-N-803-Plus-BCG-for-Patients-with-BCG-Unresponsive-Non-Muscle-Invasive-Bladder-Cancer-Carcinoma-in-Situ
2. MERCK existed Interferon alfa-2b (INTRON A) business, causing the shortage and made BCG plus Interferon alpha-2b treatment not available for BCG unresponsive
3. Pembrolizumab (Keytruda) plus BCG phase 3 clinical trial KEYNOTE -676. The rationale for the trial is that combining pembrolizumab and BCG therapies may provide anticancer activity superior to that of BCG monotherapy for patients with recurrent or persistent high-risk NMIBC. I know a patient who enrolled to this trial 2 years ago instead of RC upon the recurrence after initial BCG treatment. I do not know the patient's current status.
4. Theralase is doing Phase 2 clinical trial for Photo Dynamic Therapy (PDT) with their propriety Ruthenium based photosynthesis compound (Rutherrin(R)) . Cancer cells are known to increase
transferrin receptors to absorb more irons. Rutherrin gets inside the cancer cell through the transferrin receptor. Then green light laser excites electrons of Rutherrin and produces reactive oxygen species which will kill the cancer cells. The interim result of 35 patients are complete response 13%, complete and partial response 21% at 1 year. Not so impressive data so far.
5. The clinical trial for Tokyo172 strain BCG to compare Merck TICE BCG strain has been completed.
clinicaltrials.gov/ct2/show/NCT03091660
The final results have not been released; too slow as patients are still experiencing BCG shortage in the US. One interim result showed much improved recurrence free when BCG vaccine is given first followed by Tokyo-172 strain and if the patient shows positive reaction to BCG vaccine.
For NMIBC, above are what come to my mind
best
