Jazz Pharmaceuticals (NASDAQ:JAZZ) executives highlighted the company’s expanding oncology portfolio and upcoming regulatory milestones during a session at the 2026 TD Cowen Biotech Oncology Innovation Summit, with particular focus on zanidatamab in first-line gastroesophageal adenocarcinoma, or GEA.
Robert Iannone, Jazz’s executive vice president, global head of research and development and chief medical officer, said the company has made “a lot of progress” in oncology, pointing to zanidatamab’s approval in second-line biliary tract cancer, MODEYSO’s approval in high-grade glioma and ZEPZELCA’s expansion into the front-line setting for extensive-stage small cell lung cancer.
Zanidatamab Review in First-Line GEA Remains a Key Focus
Iannone said Jazz completed its submission at the end of February after rapidly assembling data that were available through the end of November. He said real-time oncology review allowed the company to provide data sets to the FDA ahead of the completed submission.
Jazz is also expecting publication of the GEA trial results in a “top-tier journal,” Iannone said. After publication, the company plans to update the National Comprehensive Cancer Network, or NCCN, and Iannone said there is a possibility of NCCN adoption even before FDA approval.
Executives Point to Broad Potential Use in GEA
Discussing the GEA data, Iannone said the trial was designed to test zanidatamab head-to-head against Herceptin. He said zanidatamab “definitively beat Herceptin” across endpoints, adding that Herceptin “really should be a historical regimen.”
Iannone said the trial also showed benefit from adding a PD-1 inhibitor, tislelizumab, to zanidatamab and chemotherapy. He noted that the study was not powered to show a difference between the two experimental arms, but said the arm including tislelizumab produced median overall survival of more than 26 months compared with less than 20 months for Herceptin and chemotherapy.
He also said the data support benefit in both PD-L1-positive and PD-L1-negative populations. Jazz believes zanidatamab’s differentiated mechanism of action may help explain the result, including receptor clustering, internalization and immune activation at the tumor site.
Jazz estimates there are about 8,000 HER2-positive GEA patients in the U.S. Iannone said the strength of the data should encourage physicians to ensure HER2 testing is performed so eligible patients can receive zanidatamab-based treatment.
On launch readiness, Iannone said Jazz expects to be prepared by the time of approval. He noted that zanidatamab is already approved in second-line biliary tract cancer, and that the same community and academic physicians often treat both biliary tract cancer and gastric cancer.
John Bluth, Jazz’s head of investor relations, said it may be difficult for the company to distinguish biliary tract cancer sales from GEA sales because of overlap among prescribers, though the indications use different dosing regimens. He said Jazz expects growth in Ziihera, the brand name for zanidatamab, to be driven by GEA uptake, with revenue serving as the key launch metric.
Breast Cancer and Tumor-Agnostic Opportunities Remain in Development
Iannone also discussed Jazz’s ongoing breast cancer work with zanidatamab, including a later-line study in patients previously treated with ENHERTU. He said the trial is accruing well and is expected to complete enrollment around midyear next year, with results possible as early as late 2027.
He said Jazz moved into breast cancer based on accumulating evidence across settings and combinations, as well as a perceived emerging treatment gap as ENHERTU moves earlier in therapy. Iannone said Jazz had to make assumptions about the comparator arm in the post-ENHERTU setting, but declined to disclose protocol-level details.
Jazz also continues to evaluate zanidatamab through a basket trial that could potentially support a pan-tumor or tumor-agnostic indication. Iannone said the trial is also helping the company further study tumor types such as colorectal cancer and non-small cell lung cancer.
On commercial potential, Iannone said Jazz’s prior estimate was for more than $2 billion in peak sales, originally centered on biliary tract cancer, GEA and the breast cancer trial then underway. Bluth said the company may revisit the estimate as more data emerge and as zanidatamab enters new areas.
ZEPZELCA Front-Line Expansion Highlighted
Iannone also addressed ZEPZELCA’s performance following its move into the front-line setting for extensive-stage small cell lung cancer. He said Jazz recognized early that many patients progress quickly after induction chemotherapy and that some do not make it to second-line therapy.
He said the company demonstrated ZEPZELCA could be used safely as maintenance therapy with significant benefit, including an overall survival benefit. Iannone also pointed to ASCO abstract data involving tumor-associated macrophages, saying tumors with high levels of those immune-suppressive cells do not do as well with atezolizumab alone, while the combination arm performed well.
Iannone said the key message is that ZEPZELCA is likely to have its “best effect” in the front-line setting, in combination with immunotherapy, rather than being saved for later lines of treatment.
About Jazz Pharmaceuticals (NASDAQ:JAZZ)
Jazz Pharmaceuticals plc is a global biopharmaceutical company focused on developing and commercializing therapies in neuroscience and oncology. The company’s research and development efforts target unmet medical needs in sleep disorders, hematologic malignancies, rare neurological conditions and solid tumors. Jazz’s product portfolio includes therapies for narcolepsy, hepatic veno-occlusive disease, acute myeloid leukemia and other serious disorders.
Flagship products from Jazz Pharmaceuticals include Xyrem® (sodium oxybate) and Xywav® (calcium, magnesium, potassium, and sodium oxybates) for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy.
