Timing and fitting with Roche is quite impressiveThe bladder cancer market is a huge one for many big pharmas, as per the article below. None have really succeeded. Our technology is good for NMIBC and MIBC, as per TLT news releases.
Given the fact that Roche and TLT have in common 3 fields of oncology (urology (NMIBC), neurology (GBM) and pulmonary (NSCLC)), there's a ground for collaboration if Roche recognizes the superiority and elegance of PDT/PDC over immunotherapies. They can clearly have the first mover advantage if they jv with us wisely.
June 2017:
Roche’s shocking Tecentriq fail raises red flag for bladder cancer rivals Nov. 2022:
Roche's Genentech Withdraws Tecentriq Indication for Certain Patients with Metastatic Bladder Cancer March 2021:
Roche joins the FDA accelerated approval revamp team, nixing a Tecentriq bladder cancer nod After similar moves by fellow immuno-oncology players Bristol Myers Squibb, AstraZeneca and Merck & Co.,
Roche has pulled a Tecentriq bladder cancer indication amid a long-overdue FDA campaign targeting accelerated approvals that have failed in confirmatory studies. Roche is pulling Tecentriq’s approval in patients with
metastatic urothelial carcinoma previously treated with chemotherapy, the company said Monday.
Like the three other companies that withdrew PD-1/L1 indications recently, the Swiss drugmaker said it had made the decision as part of the FDA’s industrywide review of accelerated approvals.
Before it, AstraZeneca said it would remove the same second-line bladder cancer approval from Imfinzi’s U.S. label after the drug failed a confirmatory trial in previously untreated patients.
Second-line bladder cancer was actually Tecentriq’s entry ticket into the U.S. market, making the Roche drug the first in the PD-1/L1 class to reach this type of cancer. That original 2016 go-ahead was based on tumor shrinkage data from the phase 2 IMvigor210 study.
But data unveiled in 2017 from the phase 3 IMvigor211 trial showed Tecentriq wasn’t better than chemotherapy at extending the lives of previously chemo-treated patients who had at least 5% of PD-L1 expression in tumor-infiltrating immune cells. That confirmatory trial failure threatened Tecentriq’s application in the indication. But the FDA allowed the drug to keep that nod—without converting it to a regular approval, though. Instead, the agency designated the phase 3 IMvigor130 study in previously untreated patients as the new confirmation study. That trial produced top-line data in 2019, demonstrating the
combination of Tecentriq and chemo reduced the risk of tumor progression or death by 18% over solo chemo, regardless of PD-L1 status.
At that interim analysis, overall survival showed a trend for improvement with the combo, but it fell short of crossing the statistical significance bar. While that study remains ongoing for final overall survival results, “the treatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergence of new treatment options,” Roche’s Genentech said in a statement. Remember that Roche bought Genetech in 2009 for 46B$US!!! TLT delivers solid tumor destruction. Not just shrinkage of tumors. Maybe Roche would see us as its next oncology platform. Remember that creation of the Theralase Anti-Cancer Research Center and its purpose?