USA News Group – English actor, comedian and Monty Python alumnus Eric Idle credits early detection for his victory over pancreatic cancer, known as the world’s deadliest common cancer. “The good news is that we are starting to fight back,” said Idle after creating the Bright Side Fund to support research and help promote early detection. Despite US cancer death rates being down across all age groups, however mortality rates for pancreatic cancers have gone up, so there’s much work to be done. Now there’s developments in the fight against pancreatic cancer coming that are generating huge amounts of optimism from biotech groups such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Roche Holding AG (OTC:RHHBY), Eli Lilly and Company (NYSE:LLY), Bristol-Myers Squibb Company (NYSE:BMY), and BioNTech SE (NASDAQ:BNTX).
One of the most promising new data sets in pancreatic cancer therapies is coming from pelareorep, developed by Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC). In the company’s latest round of results from the ongoing multi-indication phase 1/2 GOBLET study, patients treated with a combination of pelareorep, with atezolizumab from Roche Holding AG (OTC:RHHBY), gemcitabine from Eli Lilly and Company (NYSE:LLY), and nab-paclitaxel from Celgene Corporation which is a subsidiary of Bristol-Myers Squibb Company (NYSE:BMY).
Highlighting the impressive significance of the data, Oncolytics Biotech cites the Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine study published in 2013 by Dr. Von Hoff in the New England Journal of Medicine, which later that year led to the FDA approval of nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer.
Now the pelareorep combination has produced data that to-date was almost unheard of, with nearly triple the objective response rate (ORR) with 69% vs 23-29% of the 2013 study.
Perhaps even more significant, was the presence of a confirmed complete response (CR)—defined as the disappearance of all signs of cancer in response to treatment. Oncolytic Biotech’s pelareorep trials produced a 7.7% CR (1 in 13) of test patients, compared to only 0.12% CR (1 in 861) from the 2013 group.
“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,” said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech. “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.”
On top of the impressive ORR and CR, Oncolytics Biotech’s pelareorep also achieved a clinical benefit rate (CBR) of 85% as of the SITC poster’s data cutoff date of October 12, 2022. In comparison, a 1997 gemcitabine trial only delivered a 23.8% CBR.
Back in June, Oncolytics Biotech announced it had achieved success criteria for efficacy in its pancreatic cancer cohort. Now as of their latest abstract’s cutoff date, seven of ten evaluable patients in the cohort achieved a partial response. An additional two patients achieved stable disease for an ORR and clinical benefit rate of 70% and 90%, respectively.
“The impressive results being presented at SITC, together with prior clinical data providing a strong mechanistic rationale for the apparent synergies being displayed by pelareorep, PD-L1 inhibition, and chemotherapy, support our pancreatic cancer program’s advancement into a pivotal trial,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “We look forward to discussions with regulators to enable these efforts and align on the optimal design for a licensure-enabling study. In parallel, we continue to make strong progress with our breast cancer program; and are thrilled to be advancing a pipeline that includes two potentially compelling registration opportunities.”
With this latest data from GOBLET, it appears that the fastest route to a catalyst event will go through its combination with chemotherapy and checkpoint inhibition to treat pancreatic cancer.
“These latest results indicate that pelareorep’s immunotherapeutic effects may enhance the efficacy of checkpoint inhibitors in pancreatic cancer and increase tumor response rates,” said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. “This promising finding suggests that pelareorep has the potential to dramatically improve the current therapeutic approach is an indication that is amongst the most difficult to treat.”
Another joint effort involving Roche Holding AG (OTC:RHHBY) that sparked early optimism this year was an mRNA therapy for pancreatic cancer developed with BioNTech SE (NASDAQ:BNTX). Back in June, BioNTech presented preliminary Phase I data of its BNT122, evaluating with Genentech (a Roche subsidiary) in pancreatic cancer.
The Phase I trial is studying the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (BNT122) in combination with atezolizumab, an anti-PD-L1 immune checkpoint inhibitor, and chemotherapy. The patients in the study have resected pancreatic ductal adenocarcinoma (PDAC).
“With only under 5% of patients responding to current treatment options, PDAC is one of the highest unmet medical need cancers,” said Dr. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer of BioNTech. “We are committed to take up this challenge by leveraging our long-standing research in cancer vaccinology and are trying to break new ground in the treatment of such hard-to-treat tumors.”
For Eli Lilly and Company (NYSE:LLY), the new developments with gemcitabine involved in pancreatic cancer therapies is a marked improvement upon the disappointment in 2019 that resulted after a $1.6 billion buyout of Armo Biosciences led to ending a Phase 3 study for pegilodecakin resulting from a poor showing in pancreatic cancer.
Initially Bristol-Myers Squibb Company (NYSE:BMY) had more success with its massive $74-billion acquisition of Celgene in 2019, which led to obtaining the asset Abraxane—the brand name of nab-paclitaxel which is approved in breast, lung, and pancreatic cancer.
However, Celgene was recently hit with an FDA warning letter because the BMS subsidiary didn’t fix the problem of multiple media fill failures along the aseptic processing line at its biologics plant.
French biotech giant Ipsen S.A. and its combination involving its asset Onivyde also demonstrated a statistically significant improvement in overall survival (OS) compared to the nab-paclitaxel+gemcitabine combination in patients with metastatic pancreatic ductal adenocarcinoma. The win for Ipsen comes roughly five years after the company paid potentially $1 billion for the pancreatic cancer drug, acquiring it from Merrimack Pharmaceuticals in 2017.
Onivyde is also approved for patients with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection and is currently in a phase 3 confirmatory study in combination with Roche’s Rituxan and Bristol Myers Squibb’s Revlimid in patients with relapsed/refractory follicular lymphoma who have received at least one prior therapy.
Article Source: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/
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