DAIICHI SANKYO, INC.

Jazz Pharmaceuticals' HER2-directed bispecific antibody Ziihera gains FDA approval for biliary tract cancer (BTC), with potential for broader indications like HER2-positive breast and gastric cancers. The approval is based on a 52% objective response rate in the HERIZON-BTC-01 trial, with Jazz aiming for peak sales of $2 billion. The company is also conducting phase 3 trials in gastroesophageal adenocarcinoma and breast cancer.

The non-small cell lung cancer market is driven by increasing NSCLC cases, uptake of immune checkpoint inhibitors, emerging premium therapies, and awareness of mutations. DelveInsight's report covers current treatment practices, emerging drugs, market share, and forecasted market size from 2019 to 2032 in 7MM. Key companies and therapies include EMD Serono, Merck, AstraZeneca, Bristol-Myers Squibb, and therapies like M1774, C-TIL051, and Osimertinib. FDA approvals for Opdivo and Tagrisso in 2024 highlight advancements in treatment.

Fanaroff: Research grants from American Heart Association and National Institutes of Health; consulting fees from Abbott Laboratories. Vora: Consulting fees from Medtronic. Mehran: Institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, OrbusNeich; consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, Sanofi; consulting (no fees) for Regeneron Pharmaceuticals Inc; institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol Myers Squibb, Novartis, Watermark Research; Executive committee member for Janssen Pharmaceuticals and Bristol Myers Squibb; <1% equity in Claret Medical and Elixir Medical. Granger: Research grants from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, US Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, Novartis; consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, Rho Pharmaceuticals. Goodman: Research grant support and/or speaker/consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Esperion, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Novo Nordisk A/C, Pfizer, Regeneron, Sanofi, Servier, Tenax Therapeutics, Heart and Stroke Foundation of Ontario/University of Toronto, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Duke Clinical Research Institute, PERFUSE. Aronson: Employee of Bristol Myers Squibb. Windecker: Institutional research and educational grants from Abbott, Amgen, Bayer, BMS, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, Sinomed. Alexander: Research grants from Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, VoluMetrix; consulting fees from Pfizer, Bristol Myers Squibb, AbbVie Pharmaceuticals, CSL Behring, Novo Nordisk, Portola Pharmaceuticals, Quantum Genomics, Teikoku Pharmaceuticals, VA Cooperative Studies, Zafgen. Lopes: Research grants from Bristol Myers Squibb, Pfizer, Amgen, Inc, GlaxoSmithKline, Medtronic PLC, Sanofi Aventis; consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer AG. The other authors report no conflicts.

The ADC market is projected to reach $47 billion by 2029, driven by cancer prevalence and precision medicine advancements, but toxicity remains a key challenge. Major players like Roche, Daiichi Sankyo, Pfizer, and Gilead lead innovation through collaborations, focusing on improving linker technologies, payload delivery, and antibody selectivity to mitigate adverse effects.

Pharma leaders discussed clinical trial quality at SCOPE Europe, emphasizing the shift from reactive to proactive, risk-based approaches. Challenges include cultural resistance and high implementation costs, highlighting the need for senior leadership support and data-driven decision-making to ensure quality and efficiency in clinical trials.

GRAIL, Inc. announced the first patient tested with its investigational Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the TROPION-Lung12 Phase 3 study, sponsored by AstraZeneca in collaboration with Daiichi Sankyo. The study aims to evaluate adjuvant treatment regimens in Stage I adenocarcinoma NSCLC patients, using GRAIL's methylation platform to detect ctDNA without requiring tissue analysis.

Syndax Pharmaceuticals' drug Revuforj, a menin inhibitor, received FDA approval for treating acute leukemia with KMT2A translocation, offering a new treatment option for patients with poor prognoses. The drug, priced at $39,500/month, showed promising results in a Phase 1/2 study, with 21.2% achieving complete remission. Revuforj carries a black box warning for differentiation syndrome risk.

Vera Therapeutics appoints Jason S. Carter as Chief Legal Officer, enhancing its team for the pivotal ORIGIN 3 trial of atacicept in IgAN, with topline results expected in Q2 2025 and a planned BLA submission to the FDA.

FDA reviewing BLA for Dato-DXd, seeking accelerated approval for EGFR-mutated NSCLC. AstraZeneca and Daiichi Sankyo withdrew previous BLA for nonsquamous NSCLC based on TROPION-Lung01 phase 3 data. New BLA submission based on TROPION-Lung05 phase 2 data, supported by TROPION-Lung01 phase 1 and TROPION-PanTumor01 phase 3 findings. Updated findings to be presented at ESMO Asia 2024.