Next-generation antibody-drug conjugates, bispecifics, radiopharmaceuticals, tyrosine kinase inhibitors ... Fierce provides a deep dive into the hunt for the next Enhertu in breast cancer. ESMO 2026 data featured Chinese assets backed by Big Pharma. Gilead and Astellas struck $1 billion-plus deals for immunology and immuno-oncology assets. And more.
BioNTech sees ‘limited’ benefit to ADC after phase 3 reveals modest efficacy, ILD cases
As Daiichi Sankyo and AstraZeneca’s Enhertu marches into earlier lines of HER2 breast cancer treatment and becomes the world's best-selling ADC, drugmakers are facing an uphill battle trying to develop new breast cancer options upon Enhertu progression or to replace it. Case in point, BioNTech’s DualityBio-partnered t-pam showed “modest” progression-free survival benefit and a higher-than-expected interstitial lung disease rate in a phase 3 trial in HR-positive, HER2-low breast cancer. Fierce took a deep dive into the current HER2 breast cancer drug development landscape.
2. ESMO: Merck, Kelun’s ‘workhorse’ ADC posts major tumor progression benefit in PD-L1-negative NSCLC
ESMO: In sac-TMT’s first global phase 3 win, Merck sees ‘pretty consistent’ data with China
Merck outlines 2027 as ‘another year of investment’ despite recent clinical wins
Merck & Co.’s sac-TMT, used alongside Keytruda, reduced the risk of progression or death by 51% versus Keytruda-chemo in first-line, PD-L1-negative non-small cell lung cancer in a China phase 3 conducted by Kelun-Biotech. Meanwhile, in sac-TMT’s first global phase 3 readout, Merck saw “very consistent” endometrial cancer data with previous Chinese results. The New Jersey pharma now plans to move its PD-1xVEGF candidate into phase 3 development, including combinations with sac-TMT, in first-line NSCLC.
3. ESMO: Bristol Myers CMO touts ‘5 out of 5’ positive phase 3 trials for bispecific ADC iza-bren
Bristol Myers Squibb’s EGFRxHER3 ADC iza-bren, showed 60% and 59% PFS benefits in two China phase 3 trials in previously treated EGFR-mutant NSCLC and HR-positive, HER2-negative breast cancer, respectively. BMS’ chief medical officer, Cristian Massacesi, M.D., called the drug’s clean sweep of five positive phase 3s “quite remarkable.”
4. ESMO: Takeda’s $1.2B bet on Innovent ‘absolutely’ pays off with details of ADC’s phase 3 win
Takeda’s CLDN18.2 ADC, licensed from Innovent Biologics, improved median overall survival to 10.2 months, versus 6.9 months for investigator-selected regimens, in a phase 3 trial for third-line CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. While approval bids are underway in Japan and China, Takeda plans to start global phase 3 trials for the drug in gastric and pancreatic cancer.
5. Gilead to pay $1.3B upfront for PepStar’s oral IL-23 challenger to J&J’s Icotyde
Gilead will acquire PepStar Therapeutics’ oral IL-23 receptor inhibitor program for $1.275 billion. The drug would be a rival to Johnson & Johnson’s Icotyde, which the FDA approved for plaque psoriasis in March. BMO Capital Markets analysts noted that less frequent dosing and the potential to combine with Gilead’s emvistegrast could represent key points of differentiation for the candidate.
6. Astellas makes $1.3B bet on Audax’s preclinical push to reverse decades of IL-12 woes
Astellas is offering up to $285 million in upfront and option fees to potentially license a preclinical IL-12 program from Audax Biosciences. Up to $1.05 billion in milestones are up for grab if the cytokine-antibody fusion molecule can address the dosing and toxicity issues that have thwarted IL-12 as an immuno-oncology drug class.
Other News of Note:
7. ESMO: AZ, Hutchmed’s Orpathys combo shows post-Tagrisso power in MET-driven lung cancer
9. ESMO: BMS’ Massacesi hails ‘very promising’ data for BioNTech-partnered PD-L1xVEGF-A drug
10. GSK’s B7-H3 ADC drives 67% cancer risk reduction in Hansoh's phase 3 China trial
11. ESMO: GSK cancer R&D chief says mo-rez data ‘reinforces our belief’ in ADC as phase 3 push ramps up
12. WuXi AppTec bucks DOD uncertainty through Q3, lifting forecast for 2026
13. Ascletis’ challenger to Lilly’s Foundayo hits goals in phase 2 diabetes trial
14. Sun locks in first DTC spot for alopecia areata med Leqselvi