FN Media Group Presents USA News Group News Commentary
Vancouver, BC – September 20, 2023 – USA News Group – Earlier this year, the US White House requested over $2.8 billion in funding from Congress for their “Cancer Moonshot” initiative, an ambitious plan to slash cancer rates in half within the next quarter-century. Already, 2023 is brimming with encouraging progress in the biotech sector that is boosting our hope in the battle against cancer. Simplifying the jargon, this includes major breakthroughs in treatments that are prolonging the time before cancer worsens (known as progression-free survival or PFS) and increasing the rate at which patients respond positively to treatment (overall response rate or ORR). This inspiring progress has been led by companies like from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Eli Lilly and Company, ImmunoGen, Inc. (NASDAQ:IMGN), Merck &Co., Inc. (NYSE:MRK), and AstraZeneca PLC (NASDQ:AZN).
Accompanying its oral presentation at the 2023 ASCO Annual Meeting, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has unveiled impressive results from its Phase 2 trial of a drug for metastatic breast cancer, offering a promising avenue for those with the disease and catching the eye of RBC Capital.
The trial, known as BRACELET-1, tested a therapy that combines the company’s drug, pelareorep, with a common cancer treatment, paclitaxel. The results showed that this combo treatment could substantially slow the progression of the disease. In fact, the risk of the disease getting worse was reduced by an impressive 71% compared to paclitaxel alone, through its progression-free survival (PFS).
For patients, this could mean more time to enjoy life without the burden of worsening symptoms. To put it into numbers, patients on the combo therapy had a median of 9.5 months before their disease progressed, compared to just 6.3 months for those on paclitaxel alone.
The combo therapy also increased the overall response rate (ORR), which is the percentage of patients whose cancer shrinks or disappears after treatment. An impressive 37.5% of patients responded to the combo therapy, while only 13.3% did to paclitaxel alone. This means that the combo therapy is more likely to work for a larger number of patients.
“BRACELET-1’s positive results complement prior phase 2 data showing a statistically significant increase in overall survival when pelareorep was combined with paclitaxel by demonstrating similar stark improvements in PFS and ORR in less heavily pre-treated patients,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “Given this exciting finding, our next step is to discuss our data with the FDA to enable our breast cancer program’s expeditious advancement to a registrational study with dual PFS and OS endpoints. Including a PFS endpoint will substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep’s path to potential approval as we work to address the urgent needs of HR+/HER2- breast cancer patients.”
Following these encouraging results, Oncolytics Biotech is now ready to take the next steps. The company is planning to discuss its data with the FDA and work towards advancing its breast cancer program to a registrational study. This study will play a crucial role in securing the approval of pelareorep as a breast cancer treatment. Already in late 2022, Oncolytics Biotech received Fast Track Designation from the US Food and Drug Administration (FDA) for pelareorep in the treatment of advanced/metastatic pancreatic cancer.
Eli Lilly and Company also shared new data on two of its key cancer treatments, Verzenio® (abemaciclib) and Jaypirca (pirtobrutinib), at the 2023 ASCO Annual Meeting.
The results from the Phase 3 monarchE trial of Verzenio demonstrated similar efficacy across age groups and even in patients requiring dose adjustments. Used for treating high-risk, early-stage breast cancer, Verzenio also showed similar quality of life metrics to endocrine therapy alone. These findings strengthen the case for Verzenio as a standard of care for early breast cancer patients.
Additionally, updated data from the Phase 1/2 BRUIN trial for Jaypirca confirmed its efficacy in patients pre-treated with covalent BTK inhibitors who have relapsed or refractory Mantle Cell Lymphoma (MCL). The continued demonstration of durable efficacy, along with no newly identified safety signals, builds confidence in the treatment potential of Jaypirca.
“These additional data on Verzenio and Jaypirca build on the evidence supporting the role each of these medicines play in improving the treatment paradigms for patients with node-positive, high risk early breast cancer and covalent BTK inhibitor pre-treated relapsed or refractory MCL, respectively,” said David Hyman, M.D., Chief Medical Officer, Loxo@Lilly.
Another company working on advanced cancer drugs, ImmunoGen, Inc. (NASDAQ:IMGN), recently shared some of their own good news involving their drug ELAHERE® which they tested in a big study known as the MIRASOL trial. This trial involved patients with a specific type of tough-to-treat ovarian cancer, and so far ELAHERE® has demonstrated statistically significant improvements in PFS, ORR, and overall survival (OS), including a 33% reduction in the risk of death in the ELAHERE® group versus the investigator’s choice of a single-agent chemotherapy.
“I believe the data from the confirmatory MIRASOL trial are practice-changing,” said MIRASOL Principal Investigator Kathleen Moore. “I am confident that, with the MIRASOL data, ELAHERE has the potential to become the new standard of care for patients with FRα-positive, platinum-resistant ovarian cancer.”
Patients using ELAHERE® had more time without their cancer getting worse, and a larger percentage of them saw their cancer shrink or disappear. Plus, ELAHERE® also increased the overall lifespan of these patients, a first for this type of ovarian cancer.
Because of these great results, ImmunoGen plans to take ELAHERE® to the next level. They’re getting ready to ask for official approval to market the drug in Europe and the US. This means ELAHERE® could soon be an option for ovarian cancer patients who don’t respond to other treatments.
Two big names in the drug-making industry, AstraZeneca PLC (NASDQ:AZN) and Merck &Co., Inc. (NYSE:MRK), just got a thumbs-up from the FDA for their drug LYNPARZA. This drug, when used with two others called abiraterone and either prednisone or prednisolone, is now approved for treating a stubborn type of prostate cancer that doesn’t respond to other therapies.
In a large study called the PROpel trial, the combo of LYNPARZA and the other two drugs helped stop the cancer from getting worse. It was found to work best in patients with a specific genetic mutation (BRCA mutation).
Prostate cancer is quite common in the US and can get worse quickly. Roughly 10% of stubborn cases have the BRCA mutation, which usually predicts poor outcomes. That’s why this approval is a big deal—it’s an effective new treatment for these patients.
“There is a critical unmet need for new first-line treatment options for patients with BRCAm mCRPC, and this approval underscores the importance of BRCA testing at metastatic diagnosis,” said Dave Fredrickson, Executive VP, Oncology Business Unit, AstraZeneca. “We look forward to bringing the benefit of this LYNPARZA combination to patients earlier in their treatment.”
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