Oncolytics Biotech Inc T.ONC

Phase 1/2 AMBUSH Trial

[Noteable]

Sponsor:

University of Southern California

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University of Southern California

Standard Doses of Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial

https://clinicaltrials.gov/ct2/show/NCT05514990

[Capitalista]

Thanks, Noteable.  Turns out I was using bad search terms - I tried AMBUSH trial pelareorep and it popped right up.  

[Noteable]

This investigator sponsored phase I/II trial is looking at the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory) (RRMM). https://clinicaltrials.gov/ct2/show/NCT05514990

[Noteable]

November 07. 2022 - GSK’s Blenrep (belantamab mafodotin) missed on its Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), the company announced Monday, possibly putting the drug’s continued approval at risk. The DREAMM-3 study was a head-to-head superiority study that evaluated Blenrep alone compared to pomalidomide in combination with low-dose dexamethasone

[Noteable]

The GSK antibody-drug conjugate (ADC) Blenrep didn’t outdo Bristol Myers Squibb’s Pomalyst and low-dose dexamethasone at slowing disease progression or death, the company said Monday. The DREAMM-3 trial flop is a blow to GSK’s oncology ambitions; the British pharma has projected Blenrep could reach more than 3 billion pounds sterling in peak sales. And it puts Blenrep’s accelerated approval

[Noteable]

Blenrep also didn’t do much better at shrinking tumors, with a response rate of 41% compared with 36% for the control group. It so far also showed no benefit at preventing deaths. At the time of the analysis, when 37.5% of the trial patients had died, Blenrep and control arms recorded median survival of 21.2 months and 21.1 months, respectively. Patients on the GSK drug had a 14% higher risk of

[Noteable]

Despite the trial flop, there may be hope for the GSK drug. The FDA has previously allowed cancer accelerated approvals to remain on the market despite a confirmatory fail, especially when another study that could serve as the new confirmatory trial nears a readout. Given the imminent readout from the other two DREAMM studies, the FDA likely won’t act on Blenrep now. But the FDA’s decision to

[Noteable]

November 08, 2022 post. https://twitter.com/pelareorep/status/1590141039226277888?s=46&t=2A8lOimOUAkgIMfmUtvowQ

[Noteable]

The Ambush Phase 1/2 clinical trialis looking at the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory) (RRMM). https://clinicaltrials.gov/ct2/show/NCT05514990