VANCOUVER, BC — According to the European Cancer Information System (ECIS), new cancer cases and deaths are on the rise in the EU. Sadly, this is a trend that’s happening in North America too, especially among young people. Perhaps the most concerning are the incidences of pancreatic cancer, which while only being the 4th most common cause of death, remains one of the lowest survival rates among all cancers. Despite the dire odds, several biotech developers are working diligently to find treatments to enhance the chances of those who’ve been unlucky enough to contract pancreatic cancer. Among the top developers putting out promising results with new treatments are Oncolytics Biotech Inc., Exelixis Inc., Mirati Therapeutics Inc., Eli Lilly and POINT Biopharma Global Inc.
One of the latest developments from Oncolytics Biotech Inc. is an update on its flagship asset, pelareorep, and its ongoing GOBLET Phase 1/2 study. Within its pancreatic cancer segment, the study has delivered plenty of optimistic results, with the latest update coming at the European Society for Medical Oncology (ESMO) Congress 2023, at the IFEMA Madrid Conference Center in Madrid, Spain.
Late last year, favourable data from trials involving pelareorep in treating pancreatic cancer led to the FDA rewarding it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer. By mid-2023, the Pancreatic Cancer Action Network (PanCAN) selected pelareorep for their pivotal Phase 3 trial, called Precision Promise.
Upon the announcement that pelareorep had been chosen, the market swiftly reacted, boosting ONCY’s stock. The company successfully secured an additional US$15 million, to advance their trials for both pancreatic and metastatic breast cancers. This funding round even included substantial backing from an institutional investor. As per their most recent Q2 2023 financial report, Oncolytics had a pro forma balance of CAD$42.7 million as of June 30, 2023. This is projected to sustain the company’s operations until H2 2024.
Within the GOBLET study’s latest data on pelareorep in combination with the PD-L1 inhibitor atezolizumab (atezo) and chemotherapy is new data, including a 6-month progression-free survival (PFS) rate was 72.9%, and a 6-month overall survival (OS) rate of 82.1%—both significantly high for the industry standard.
A 72.9% PFS at 6 months is a positive signal, as many other therapies struggle to reach such a high percentage of patients experiencing no progression at that point. The same goes for a 6-month OS of 82.1%, as it indicates that a significant majority of patients are surviving to this point, which is better than what is commonly seen. For reference, considering all stages of pancreatic cancer, only around 25 in every 100 (25%) survive their diagnosis for 1 year or more.
As well, the pelareorep combination therapy’s overall response rate (ORR) was 62%. For reference, Oncolytics’ 62% ORR is more than double the historical control trial titled Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine which yielded only a ~25% ORR.
Back in August, Exelixis, Inc. announced it had ended its Cabometyx study early, after researchers saw “dramatic improvement” in neuroendocrine tumors treated with cabozantinib (CABOMETYX)—namely patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors who progressed after prior systemic therapy. According to GlobalData analysts, Cabometyx’s projected total annual sales could reach $3.3 billion by 2029, driven by its strong performance in its approved indications and label-expanding studies.
“As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors whose disease has progressed after prior therapy, we are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers,” said Will Berg, M.D., Senior Vice President, Medical Affairs, Exelixis. “We are grateful for the recommendation of the Data and Safety Monitoring Board to unblind the CABINET study early due to a dramatic improvement in efficacy and look forward to discussing these findings with the U.S. Food and Drug Administration.”
In June 2023, researchers announced they’d found a “highly synergistic” combo featuring Krazati from Mirati Therapeutics, Inc. in pancreatic cancer models. The researchers found they could overcome drug resistance in combination with the FDA-approved pan-ERBB inhibitor Afatinib.
Now Mirati’s successes will be passed along to Bristol Myers Squibb, which entered a definitive merger agreement to be acquired for up to US$5.8 billion in value.
Another pharma giant making oncology moves is Eli Lilly and Company which is set to acquire POINT Biopharma Global Inc. for an aggregate of approximately US$1.4 billion.
Among the assets that Lilly will be acquiring is PNT2004, which POINT Biopharma, within its Phase 1 FRONTIER clinical trial, was evaluating five FAP-avid cancer indications, including pancreatic. As of the time of the Lilly acquisition, the FRONTIER study was still underway, and as of the ASCO Annual Meeting in May 2023, still included pancreatic cancer as a segment.
“The combination of POINT’s team, infrastructure and capabilities with Lilly’s global resources and experience could significantly accelerate the discovery, development and global access to radiopharmaceuticals,” said Joe McCann, Ph.D., CEO of POINT. “I look forward to a future where patients all over the world can benefit from the new cancer treatment options made possible by the joining of our two companies today
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