April 17–22, 2026 · San Diego · 2418 items
← Breast cancer: HER2 de-escalation, MRD, TNBC
8 people · 8 posts · 3 abstracts
zanidatamab binds two HER2 domains at once (the trastuzumab and pertuzumab sites) and does not lean on chemo cytotoxicity.
| Drug / trial | Readout | Setting |
|---|---|---|
| zanidatamabzanidatamab | No-chemo neoadjuvant pCR 30% | NeoZanHER · below a registration bar |
Ankur Karmokar, Emanuele Loro, Al Hassan Kyakulaga, Desmond Lau, Nina Weisser, Genevieve Desjardins, Prajwal Raghunatha, Edwin Clark, Robin Humphreys, Kedar S. Vaidya
Read the abstract →Vicente Valero, Paula R. Pohlmann, Jason Mouabbi, Xuelin Huang, Wei Qiao, Heather R. Alonzo, Rashmi Krishna Murthy, Gaiane M. Rauch, Taiwo Adesoye, Cristina M. Checka, William F. Symmans, Dmitri Grachev, Flora Alajajyan, Adaeze Nwosu-Iheme, Amy Hassan, Miral Mahesh Patel, Sharon H. Giordano, Kelly Hunt, Debasish Tripathy, Funda Meric-Bernstam
Read the abstract →Vivek Subbiah, Vicky Makker, Do-Youn Oh, Elizabeth Gardener, Elaina Gartner, Funda Meric-Bernstam
Read the abstract →On August 25, 2026, the FDA approved the HER2 bispecific antibody zanidatamab for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma confirmed by an FDA-approved test. One approval covers zanidatamab combined with tislelizumab plus fluoropyrimidine and platinum chemotherapy for patients with HER2-positive disease defined as IHC 3+ or IHC 2+/ISH+. The approvals were based on the HERIZON-GEA-01 study.
Why it matters: FDA approval of a new first-line HER2-positive gastroesophageal adenocarcinoma regimen affects treatment options for clinicians.
The FDA on August 25, 2026 approved Ziihera (zanidatamab-hrii) for first-line unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: IHC 3+ and IHC 2+/ISH+ patients can receive it with tislelizumab plus chemotherapy, and IHC 3+ patients with chemotherapy alone. Under the BeOne Medicines collaboration, Zymeworks has received $81 million, with up to $144 million in further milestones and tiered royalties of up to 19.5%. The approval triggers the structure set up on March 2, 2026, when Zymeworks BC moved 30% of future Ziihera royalties into Zymeworks Royalty Limited Partnership, which borrowed $250 million in non-recourse notes from Royalty Pharma secured solely on those royalties.
Why it matters: FDA approval of a bispecific antibody in first-line gastric cancer activates milestone payments and a $250 million royalty-backed financing.
The US FDA approved a new indication for tislelizumab on August 26, 2026, combining it with zanidatamab plus chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA). The approval covers patients regardless of PD-L1 expression and is the first approved regimen pairing a HER2 bispecific antibody with a PD-1 inhibitor. It rests on the HERIZON-GEA-01 trial, published in the New England Journal of Medicine and presented orally at the 2026 ASCO annual meeting.
Why it matters: First approved HER2 bispecific plus PD-1 combination for first-line HER2-positive gastroesophageal adenocarcinoma.
The FDA has approved BeiGene's supplemental application for Tevimbra (tislelizumab) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma (GEA). About 20% of GEA patients are HER2-positive, a subtype that has long been difficult to treat.
Why it matters: Adds a first-line FDA-approved regimen for a hard-to-treat HER2-positive gastroesophageal adenocarcinoma population.
BeiGene said the FDA has approved a supplemental application for its PD-1 antibody tislelizumab (BaiZeAn) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. Results were published earlier this year in the New England Journal of Medicine. The material cites five-year survival below 30 percent for gastric cancer and about 19 percent for esophageal adenocarcinoma.
Why it matters: First-line FDA approval expands tislelizumab's use in HER2-positive gastroesophageal adenocarcinoma.
The US FDA approved two first-line treatment regimens combining Jazz Pharmaceuticals' HER2 bispecific antibody Ziihera (zanidatamab-hrii) with tislelizumab, a PD-1 antibody originally developed by BeiGene, on August 25. The approval adds tislelizumab to first-line combination treatment for HER2-positive gastroesophageal adenocarcinoma in the United States. The approval covers two distinct Ziihera-based regimens.
Why it matters: FDA approval extends BeiGene's PD-1 antibody tislelizumab into a US first-line indication.