Promising Developments Announced Ahead of 2023 ASCO Annual Meeting's Oral Presentations

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VANCOUVER, B.C., May 26, 2023 /PRNewswire/ -- USA News Group  -  The world's biggest cancer conference is set to roll again at American Society of Clinical Oncology (ASCO) 2023, with in-person attendance back in full swing and already 40,000 people registered by mid-May. Much like other years, there's plenty of optimism ahead for the findings and intriguing data set to be presented, with oral presentations from some of the biotech sector's finest and up-and-comers, including from Gilead Sciences, Inc. (NASDAQ:GILD), ImmunoGen, Inc. (NASDAQ:IMGN), Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN), Legend Biotech Corporation (NASDAQ:LEGN), and Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC).

Just months after seeing their flagship asset pelareorep gain FDA Fast Track Designation for the treatment of advanced/metastatic pancreatic cancer, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) is set to deliver more optimism at this year's ASCO in an oral presentation on June 3, 2023.

Seen as an honor and a sign of important data for the sector, Oncolytics was justly pleased with being selected to give an oral presentation, which will feature positive Randomized Phase 2 Data from Oncolytics' BRACELET-1 HR+/HER2- Metastatic Breast Cancer trial. Already announced, the data demonstrates that pelareorep, which is an intravenously delivered immunotherapy agent, drives ≥50% improvements in overall response rate (ORR) and median progression-free survival (mPFS) in combination with the chemotherapy paclitaxel.

According to the National Cancer Institute, HR+/HER2- is the most common cancer subtype, accounting for roughly 69% of all female breast cancer cases. By 2032, the global breast cancer market is projected to grow at a CAGR of 10.3% to US$85.5 billion.

"BRACELET-1 substantially de-risks our HR+/HER2- breast cancer program by providing a second randomized dataset showing pelareorep plus paclitaxel handily outperforming paclitaxel alone," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Importantly, evidence of pelareorep's ability to synergistically enhance paclitaxel's efficacy has now been seen consistently across multiple clinical efficacy endpoints of overall survival, progression-free survival, and ORR."

As per Dr. Coffey's statement, the cohort evaluating the combination of paclitaxel plus pelareorep showed ≥50% improvements on the trial's primary endpoint of ORR at week 16, improving to 31.3%, up from just 20% for paclitaxel alone. As well, the mPFS improvement was also significant, in that the combination was able to increase from 6.4 months to 9.6 months as of ASCO's cut-off date of October 2022. It's worth noting that Oncolytics has stated that it will also be presenting updated data from May 2023 at the oral presentation.

"With these data, our program is phase 3-ready, and efforts to expeditiously advance to a two-arm registrational study of pelareorep-paclitaxel combination therapy are well underway," added Dr. Coffey. "I would like to thank BRACELET-1's participants as well as our collaborators at Pfizer, Merck KGaA, and PrECOG, all of whom contributed to an important trial that will inform and accelerate pelareorep's path to approval."

BRACELET-1 enrolled 48 patients randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio^®). All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor.

"BRACELET-1's data greatly enhance our pipeline's value proposition, bringing our breast cancer program to pivotal trial-readiness and confirming pelareorep's potential to address large markets by synergistically combining with other anti-cancer agents," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "Looking ahead, we believe our data in breast cancer, together with the second registration opportunity offered by our pancreatic cancer program, leave us well-positioned as we continue to execute our business development efforts."

Along with its wholly-owned subsidiary Kite, Gilead Sciences, Inc. (NASDAQ:GILD) is set to present 30 abstracts during the 2023 ASCO Annual Meeting, including four oral sessions, for breast cancer, B-cell lymphomas, mantle cell lymphoma, and lung cancer (with partner Arcus Biosciences).

Amid the data to be presented, Gilead will share its own results from the Phase 3 TROPICS-02 study for Trodelvy in HR+/HER2- metastatic breast cancer. But beyond that, Kite Therapies was granted a late-breaking oral presentation from its landmark Phase 3 ZUMA-7 study that will highlight overall survival (OS) results for Yescarta versus standard of care for initial treatment of adult patients with relapsed/refractory large B-cell lymphoma within 12 months of completion of first-line therapy.

"The data that will be presented at ASCO represent another significant step forward in our goal of bringing the hope of survival to more patients through our innovative cell therapies," said Frank Neumann, MD, PhD, SVP, Kite's Global Head of Clinical Development. "We are particularly excited to share our overall survival data from the pivotal ZUMA-7 study for Yescarta for initial treatment of relapsed/refractory large B-cell lymphoma, the first and only treatment in 30 years to demonstrate a statistically significant improvement in overall survival versus historical standard of care in this patient population."

Another late-breaking oral presentation that's set to be delivered by ImmunoGen, Inc. (NASDAQ:IMGN) from its Phase 3 MIRASOL trial evaluating the safety and efficacy of ELAHERE (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer.

"Having demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to investigator's choice of single-agent chemotherapy, I believe ELAHERE has the potential to be practice changing in FRα-positive, platinum-resistant ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen.

For Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN), an oral presentation will include new clinical data from the ongoing, open label, pivotal Phase 2 FIREFLY-1 trial evaluating the investigational agent tovorafenib in recurrent or progressive pediatric low-grade glioma (pLGG)—which are the most frequent type of childhood brain tumors, accounting for approximately 30%. The primary endpoint of the FIREFLY-1 trial is overall response rate (ORR) by Response Assessment for Neuro-Oncology (RANO) criteria as assessed by blinded independent central review. 

Earlier this year, Day One announced topline data which included an ORR of 64% and clinical benefit rate (CBR) of 91% in 69 heavily-pretreated, RANO-evaluable patients. Additional data will be presented during the 2023 ASCO oral presentation.

"The responses we've observed in the FIREFLY-1 study with weekly monotherapy tovorafenib in children with recurrent or progressive low-grade gliomas are very encouraging," said Samuel Blackman, M.D., Ph.D., Co-Founder and Chief Medical Officer of Day One. "As tovorafenib progresses in the clinic, we want to thank the patients, their families, the clinical investigators, and the advocates who have chosen to participate in the FIREFLY-1 clinical trial and support the development of a potential new treatment for children in need of new therapeutic options."

Bringing in eight presentations to ASCO and EHA 2023 Annual Meetings, Legend Biotech Corporation (NASDAQ:LEGN) is set to deliver new and updated data from the CARTITUDE Clinical Development Program. CARTITUDE-4 is the first international, randomized, open-label Phase 3 study investigating the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received cilta-cel vs standard-of-care regimens, including pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), following one to three prior lines of therapy.

"We are continuing to investigate cilta-cel in earlier lines of treatment and the readout from this study is crucial to how we move forward," said Ying Huang, Ph.D., CEO of Legend Biotech. "We have taken significant steps toward advancing the treatment landscape for myeloma patients in the CARTITUDE Development Program and are exploring the potential of other agents in our pipeline for this and other indications."

For more information please visit: https://usanewsgroup.com/2022/11/27/market-uncertainty-is-creating-opportunities-that-have-somehow-been-overlooked/

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