DAIICHI SANKYO, INC.

Oncolytics Biotech seeks accelerated approval for pelareorep, planning a 2025 Phase II breast cancer trial. Positive Phase II BRACELET-1 data and FDA feedback support this move. Oncolytics' stock rose 18.22% on 4 October, with a market cap of $84.5m. Oncolytic virus therapies, currently dominated by checkpoint inhibitors, are expected to see a 20x sales increase by 2029. The planned trial will enroll 180 HR+/HER2- advanced/metastatic breast cancer patients, aiming to show a PFS benefit of at least 4.3 months.

The Antibody Drug Conjugates market was valued at USD 5,475.84 Million in 2023 and is projected to reach USD 39,153.21 Million by 2032, growing at a CAGR of 24.0%. ADCs are crucial for precision cancer therapy, with over 100 in clinical trials and eight approved since 2020. Companies like Merck and Daiichi Sankyo are expanding their portfolios and geographical reach. The market is segmented by type, product, and application, with monoclonal antibodies leading. North America dominates the ADC market, driven by the U.S. due to advanced healthcare systems and research.

E. Heath reports advisory/consulting, steering committee, honoraria/paid travel, speaker’s bureau, and research support from various companies. J.R. Ribeiro, K. Poorman, and J. Xiu report personal fees and other support from Caris Life Sciences. H. Mamdani reports other support and grants from Daiichi Sankyo, AstraZeneca, and Genentech. A.F. Shields reports personal fees from Caris Life Sciences. G.L. Lopes reports stock ownership, honoraria, consulting, research funding, travel, and other relationships with multiple companies. S.A. Kareff reports personal fees and travel grants from various organizations. M. Radovich and G.W. Sledge report other support from Caris Life Sciences. G.A. Vidal reports relationships with Guardant360, Gilead, BillionToOne, Genentech/Roche, GSK, and AstraZeneca. J.L. Marshall reports personal fees from Caris. No other disclosures were reported by the other authors.

Oncolytic virus immunotherapy, a groundbreaking cancer treatment, targets cancer cells while sparing healthy ones, offering a safer and effective alternative to conventional therapies. Advances like Oncorine, Imlygic, and Delytact highlight its potential, promising a tailored, multifaceted approach to cancer treatment.

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NSCLC with HER2 mutations, found in 3% of advanced non-squamous cases, is associated with poor prognosis and higher incidence of brain metastases. Standard first-line chemotherapy has limited efficacy, and HER2-targeted agents lag in NSCLC treatment. Recent studies using HER2 TKIs, ADCs, and monoclonal antibodies show promising results, with Trastuzumab deruxtecan (T-DXd) achieving 55% ORR and 8.2 months mPFS in DESTINY-Lung01 trial. Zongertinib, a novel HER2-specific TKI, demonstrated 62% ORR and 97% DCR in HER2 mutation-positive NSCLC patients, with low toxicity rates, suggesting a potential better tolerated treatment option.

The FDA granted priority review to a supplemental Biologics License Application for fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for treating adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer after at least one endocrine therapy. The application is supported by results from the phase IIIDESTINY-Breast06 trial, which demonstrated a median progression-free survival of 13.2 months for T-DXd versus 8.1 months for chemotherapy. T-DXd was previously granted Breakthrough Therapy Designation for this setting.

DESTINY-Breast06 trial evaluates Enhertu vs. chemotherapy in HR-positive, HER2-low/ultralow metastatic breast cancer. Enhertu, a HER2-directed ADC, is approved for various HER2-positive and HER2-low cancers. AstraZeneca and Daiichi Sankyo collaborate on Enhertu's development and commercialization.

Transthyretin amyloidosis cardiomyopathy drug development, including Pfizer's Vyndamax and BridgeBio's acoramidis, is a major focus. FDA decisions on acoramidis, AstraZeneca's dato-dxd for lung cancer, Vertex's vanza triple for cystic fibrosis, PTC's Upstaza for AADC deficiency, and Bristol Myers' subcutaneous Opdivo for solid tumors are imminent, with significant market implications.

ENHERTU granted Priority Review in the US for HER2-low or HER2-ultralow metastatic breast cancer patients who have received at least one line of endocrine therapy, based on the DESTINY-Breast06 Phase III trial demonstrating significant progression-free survival benefit. If approved, ENHERTU would be the first HER2-directed therapy and ADC for patients prior to chemotherapy. ENHERTU also received Breakthrough Therapy Designation for this patient population.