European Commission Approves Trodelvy as First-Line Treatment for Metastatic Triple-Negative Breast Cancer

AbbVie announced that the U.S. Food and Drug Administration has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan, known as Temab-A or ABBV-400, in colorectal cancer and non-small cell lung cancer. The first designation covers Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and, if indicated, anti-EGFR monoclonal antibody therapy. The second covers Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer who have previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These are the first Breakthrough Therapy Designations for Temab-A and bring AbbVie's antibody-drug conjugate portfolio to four such designations; they were primarily based on results from the first-in-human study M21-404. Temab-A is an investigational, next-generation, c-Met-directed antibody-drug conjugate with a novel topoisomerase 1 inhibitor payload and has not been approved by any global regulatory authority.

Genmab posted two fresh oncology trial readouts, including a Phase 3 win for epcoritamab in newly diagnosed diffuse large B cell lymphoma. The EPCORE DLBCL 2 trial, run with AbbVie, reported that epcoritamab plus R CHOP cut the risk of disease progression or death by 51% versus R CHOP alone in patients with higher risk DLBCL. Separately, the Phase 1/2 RAINFOL 01 study of rinatabartsesutecan, or Rina S, in platinum resistant ovarian cancer reported a 45.9% confirmed objective response rate in a heavily pretreated population, with a median duration of response of 12.1 months and no clear safety signals around eye toxicity, peripheral neuropathy, interstitial lung disease or stomatitis. The trial headlines arrive after a strong run in the shares, with the DKK2,482.0 price coming alongside a 31.18% 90 day share price return and a 23.67% year to date share price return, while the 5 year total shareholder return is down 8.75%.

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.

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.

Genmab A/S announced that its investigational antibody-drug conjugate rinatabart sesutecan, known as Rina-S, achieved a confirmed objective response rate of 45.9% among 109 treated patients with platinum-resistant ovarian cancer in Part C of the Phase 1/2 RAINFOL-01 trial. The results, presented in a Late-Breaking Oral Session at the International Gynecologic Cancer Society Congress 2026 in Montreal, Canada, included five complete responses and a median duration of response of 12.1 months, with 51% of responders still in response at one year. The study also reported a median progression-free survival of 9.5 months, and antitumor activity was observed regardless of folate receptor alpha expression levels, including in patients with low expression and non-expressors, and regardless of prior treatment with mirvetuximab. More than half of patients, 53%, had received three or four prior lines of therapy, all had received prior bevacizumab and taxane therapy, 49.5% had received a prior PARP inhibitor, and 33% had received prior mirvetuximab soravtansine. The most common treatment-emergent adverse events were fatigue at 57.8% and low-grade gastrointestinal events including nausea at 67.9%, while serious adverse events were reported in approximately one-third of participants and treatment discontinuation due to adverse events occurred in 5.5%. Rina-S is being evaluated across four Phase 3 trials in platinum-resistant ovarian cancer, endometrial cancer, platinum-sensitive ovarian cancer maintenance, and second-line platinum-sensitive ovarian cancer, plus additional Phase 1/2 and Phase 2 studies.

AstraZeneca said the FDA has granted Priority Review to a supplemental Biologics License Application for IMFINZI with enfortumab vedotin in muscle-invasive bladder cancer. The application targets patients who are ineligible for or decline cisplatin-based chemotherapy, a group with limited treatment choices. Priority Review shortens the FDA review timeline for this regimen, reflecting the agency's view that it may offer a meaningful clinical advance. AstraZeneca, a £192.8 billion pharmaceuticals group focused on prescription medicines, has been building its oncology presence across several tumour types, so any potential label expansion for IMFINZI touches a core therapy area rather than a side project for the business.