Durability, Durability, Durability A dominant theme of the Dec. 8th press release was Pela’s durability of clinical benefit. The press release itself put in bold font the first use of the word durable (“durable clinical benefit”). The Adlia Nortye president and Matt Coffey both mention durability and durable clinical responses in their quotes. Tom Heineman spoke of durability in the November 8th press release re. the GOBLET trial.
December 08, 2022 - from the Adlai Nortye press release
"These impressive results have us well-positioned to leverage Oncolytics' prior positive data and join pelareorep's global development program," said Lars Birgerson, M.D., Ph.D., Adlai Nortye President and Chief Medical Officer. "With no SAEs reported, the data suggests the favorable safety and potent anti-cancer activity displayed by the studied combination in North American HR+/HER2- breast cancer patients extends to the Chinese population. There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR. We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics."
Data from the bridging trial are expected to accelerate Adlai Nortye's development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1. IND-213 is a previously completed randomized phase 2 trial that showed a statistically significant near doubling of median overall survival when HR+/HER2- metastatic breast cancer patients were treated with paclitaxel plus pelareorep vs. paclitaxel alone. BRACELET-1 is an ongoing randomized phase 2 trial in HR+/HER2- metastatic breast cancer patients with cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 inhibitor avelumab. Oncolytics expects to report overall response rate, PFS, and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023.
Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "BRACELET-1's upcoming readout represents a crucial catalyst for Oncolytics, as data from the trial are expected to pave the way for pelareorep's advancement to a registrational breast cancer study. We believe Adlai Nortye's latest data significantly de-risk this upcoming readout as they validate IND-213's positive results by confirming the ability of pelareorep plus paclitaxel to drive durable clinical responses in HR+/HER2- breast cancer patients. I'd like to thank Adlai Nortye for the productive partnership that led to these results, providing us with added enthusiasm for the outlook of our breast cancer program."
A copy of the SABCS poster (P3-07-04), entitled, A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced/Metastatic Breast Cancer (REO 026-1), will be available on the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the symposium.
November 08, 2022 - from the GOBLET trial press release
"GOBLET's interim results indicate pelareorep may be the key to finally improving the standard-of-care for first-line treatment of pancreatic cancer, a clear need given that treatment options have not changed for many years despite their limited benefits," commented Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. "The robust efficacy signal in GOBLET markedly exceeded expectations based on historical results and is especially encouraging as most responding patients had their tumor regressions confirmed by subsequent evaluations. We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy."
November 14, 2022 - from the KOL webcast re. the GOBLET results
Dr. Andrea Bullock (56:38 of the webcast): “I think the response rate (of the pancreatic patients in the GOBLET trial) and the durability of those responses is very impressive and unlike what we have seen in other pancreatic trial and regimens. So it looks very promising and encouraging.”
Dr. Thomas Seufferlein (1:05:07 of the webcast): “In pancreatic cancer response by itself is very difficult because we’ve seen responses that did not translate (into improved overall survival). In here (the GOBLET trial) we have a combination of response and duration of response which I find far more encouraging than response by itself.”
Again the key opinion leaders highlight the durability of response as a very encouraging aspect of the GOBLET trial and why a full randomized trial is now called for.
Ultimately durability, aka overall survival, is the name of the game and where Pela shows great promise as indicated by IND-213, GOBLET, the Adlai Nortye trial, and very likely BRACELET-1. Increased durability of clinical response as demonstrated by significantly increased overall survival is what Oncolytics wants to demonstrate to the Big Pharma collaborators, and, in my opinion, that is why they are delaying the full revealing of the BRACELET-1 results until later into 1H 2013. When the more fulsome and mature data from BRACELET-1 comes out on June 2-6, 2023 at ASCO (most likely) if Roche or Pfizer have not yet made a move in regards to partnership/buyout then they will face potential competition from additional Pharma entities who will then also be apprised of the full data. I think that ONC/Y is doing a good job of setting up the needed competitive tension to get a good offer.