AstraZeneca Submits US NDA for ORPATHYS plus TAGRISSO in MET-Driven EGFR-Mutated Lung Cancer

AstraZeneca has opened its newest global strategic research and development center in Kendall Square, Cambridge, Massachusetts, part of a more than $1 billion investment in the state that will expand its Massachusetts workforce by over 50 percent in the coming years. The 570,000 square foot, 18 story site at 290 Binney Street will house nearly 2,000 researchers and scientists alongside the company's genomic medicine site at 100 Binney Street, and includes ten floors of interconnecting laboratories integrating robotics, continuous automation and agentic AI. The scientists will work on AstraZeneca's oncology, cell therapy, chronic disease and rare disease pipeline, targeting conditions such as COPD, obesity and metabolic disease, breast cancer and rare diseases, while pursuing future innovation in cell therapy and biologics to fuel growth beyond 2030. The Massachusetts investment sits within AstraZeneca's broader $50 billion US investment, and the new site joins its other US-based global strategic research center in Gaithersburg, Maryland, as part of a coast-to-coast footprint of 24 R&D, manufacturing, commercial and corporate sites. Chief Executive Officer Pascal Soriot said Kendall Square is a leading innovation ecosystem and one of the key locations where AstraZeneca will discover the next generation of scientific breakthroughs, while Massachusetts Governor Maura Healey called the investment a major vote of confidence in the state.

Summit Therapeutics has signed a clinical collaboration with AstraZeneca and its Japan-based partner Daiichi Sankyo to evaluate ivonescimab in combination with the antibody-drug conjugate Datroway, also known as datopotamab deruxtecan, across multiple solid tumors including breast and lung cancers. The collaboration is expected to initially focus on a phase III study in first-line triple-negative breast cancer, expanding ivonescimab's development into a new tumor type. Under the agreement, each company will supply its respective drug, AstraZeneca or Daiichi will sponsor the planned studies, and the companies will share study costs while retaining development and commercial rights to their own therapies. The Datroway collaboration builds on the larger deal between AstraZeneca and Summit announced in the last week, under which AstraZeneca agreed to invest $2 billion in Summit to accelerate development of ivonescimab, with the companies also set to evaluate ivonescimab alongside AstraZeneca's investigational Claudin-18.2-targeted ADC sonesitatug vedotin, or Sone-Ve, in gastrointestinal cancers. An FDA filing is under review seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment, with a final decision expected by Nov. 14, 2026.

Eli Lilly announced that the FDA has expanded the label of its oral cancer drug Jaypirca, also known as pirtobrutinib, to include a new indication in chronic lymphocytic leukemia or small lymphocytic lymphoma. Jaypirca has been approved to treat adults with previously untreated CLL/SLL who do not have a known 17p deletion, allowing the drug to be used as a first-line treatment for eligible patients. The approval is supported by data from the phase III BRUIN CLL-313 study, which showed that Jaypirca reduced the risk of disease progression or death by 80% compared to chemoimmunotherapy. Before this latest approval, Jaypirca was already approved for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor, and for adults with relapsed or refractory mantle cell lymphoma following two lines of systemic therapy including a BTK inhibitor. Jaypirca is already generating meaningful sales for Lilly, with revenues rising 66% year over year to $357 million in the first half of 2026, though its sales remain relatively small compared with Lilly's much larger obesity and diabetes portfolio.

Summit Therapeutics announced the closing of AstraZeneca's $2.0 billion strategic equity investment in the company. Under the Securities Purchase Agreement, AstraZeneca purchased approximately 108,955 shares of preferred stock convertible into Summit common stock at a 1:1,000 ratio, representing a common stock price of $18.36, a premium over the closing trading price on the day the investment was announced. The proceeds will support accelerated development of ivonescimab, a potential first-in-class investigational PD-1 / VEGF bispecific antibody, across solid tumor settings including combinations with antibody drug conjugates such as sonesitatug vedotin and Datroway. Summit Chairman and Co-Chief Executive Officer Robert W. Duggan said the investment reflects AstraZeneca's confidence in Summit and in ivonescimab's potential to redefine cancer treatment. Baker Hostetler LLP is serving as legal advisor to Summit.