Advancing Cancer Care: Shubh Goel on NIAGARA and HIMALAYA Trials

In this episode of OncoDaily, Shubh Goel, VP of Immuno-Oncology U.S. Franchise at AstraZeneca, discusses groundbreaking advances in cancer treatment. Learn about the NIAGARA trial’s success in muscle-invasive bladder cancer, showing significant improvements in PCR, EFS, and OS with perioperative immunotherapy, and the Himalaya study’s five-year survival outcomes for unresectable HCC, emphasizing liver preservation. Shubh highlights 12 positive trial readouts this year, from early to late-stage cancers, including innovative bispecific therapies targeting CTLA-4/PD-1 and PD-1/TIGIT.

Shubh Goel is the Vice President, Global Franchise Head for BiSpecifics at AstraZeneca. She also served as the VP, Head of Immuno-Oncology and GI Tumors Franchise for US Oncology at AstraZeneca, where she leaded sales, marketing, and cross-functional team efforts across the Immuno-Oncology portfolio and GI sales teams. She holds a Bachelor of Science degree in Biochemistry from the University of Bath.

Shubh previously served as the Chief Commercial Officer at Fennec Pharmaceuticals, a late-stage biotechnology company focused on improving the lives of children with cancer. Her career includes various leadership roles in commercial strategy and marketing at companies like Odonate Therapeutics, Celgene, Bayer AG, Aveo Oncology, Ariad Pharmaceuticals, and Millennium Pharmaceuticals. With over 20 years of experience, she specializes in developing and executing commercial strategies for successful oncology product launches in the U.S. and global markets.

I’m Vice President for the U.S. Franchise of Immuno-Oncology for AstraZeneca, and I’m excited to be here as we’ve had great data readouts across the world, like San Diego and now at ESMO, Barcelona, across our immuno-oncology portfolio. We’re super excited to be here at ESMO, where we’re seeing a continued evolution of our portfolio in early-stage disease for the immuno-oncology franchise. And fortunately, at this conference, we’re reading out the NIAGARA study, which is the first study in decades to read out for muscle-invasive bladder cancer patients.

With the addition of IMFINZI or durvalumab in the neoadjuvant study in chemotherapy, and then in the adjuvant setting post-surgery, we’re going to show an important benefit in EFS and OS with an improved pCR rate. This is actually consistent with other perioperative studies we had read out, including updated data that we recently shared in the early non-small cell lung cancer perioperative space. We also had from NeoCOAST-2 that was building upon the AEGEAN backbone, with additional modalities in the neoadjuvant study.

We’re awaiting further readout from the MATTERHORN study, which a perioperative study in gastric cancer, where we’ve had pCR readout already. So, we’re super excited about the evolution and the improvement in IMFINZI in perioperative setting with potentially curative intent.

NIAGARA is our global phase 3 study in the perioperative setting for muscle-invasive bladder cancer. Importantly, it’s the first phase 3 global study read out, to demonstrate positive efficacy and safety results with adding immunotherapy to the perioperative setting. So, it is the addition of IMFINZI with standard of care chemotherapy in the neoadjuvant setting, and then post-surgery IMFINZI in the adjuvant setting. What’s really exciting about this data is we not only show a positive impact on pCR with an improvement in pCR rates with the addition of IMFINZI in the neoadjuvant setting, we also see positive EFS with a hazard ratio of 0.68, and OS with a hazard ratio of 0.75 with the totality of the treatment paradigm, including the adjuvant and neoadjuvant effect.

One of the other exciting data readouts we have at ESMO is our 5-year overall survival outcome from the HIMALAYA study. Our HIMALAYA study is a study of IMFINZI-plus-IMJUDO, an anti-PD-1 and an anti-CTLA-4 agents, in the setting of first-line unresectable hepatobiliary cancer or liver cancer. What’s really exciting about this data is it builds upon our legacy that long-term survival involves multiple indications, but now, for the first time ever, we’re seeing the hope of survival of 5 years for patients with first-line HCC.

Importantly, the HIMALAYA study looks at the combination of our anti-CTLA-4 agent Tremelimumab in one single priming dose with the addition of IMFINZI, an anti-PD-1 agent, on an ongoing basis. What’s really exciting in HIMALAYA is, if you think about HCC, it encompasses two diseases in one. The physician needs to treat the liver and the cancer, and therefore, maintaining liver function, as well as delaying disease progression, is really important.

With data from our HIMALAYA study that’s been presented prior to ESMO, as well as the ESMO data, we are now seeing for the first time the hope for patients to not only live to 5 years, but also have preservation of their liver function.

What’s really great about data across two conferences here, the World Lung Cancer Conference in San Diego and now ESMO here in Barcelona, is we’re really seeing an evolution of the role that IMFINZI can play across multiple tumor types. In fact, this year alone, we’ve had 12 positive readouts, 7 indications in total from where we had two just a few years ago, and across 5 different disease areas. Let me put that into perspective. Across the two conferences, we are really seeing the outcomes changing across multiple early-stage treatment regimens. We have read out updates of data from the AEGEAN study at the World Lung Conference. We have read out here the first-ever perioperative regimen in muscle-invasive bladder cancer with the NIAGARA study, and recently at the former ASCO in 2024, we read out the first-ever study in limited-stage small cell lung cancer, showing the ADRIATIC data, which showed improved outcomes for patients with limited-stage small cell lung cancer, after cCRT.

Not only are we improving outcomes in the early-stage study, but we’re also seeing improvements in the late-stage studies. Fortunately, earlier this year, we showed for the first time ever, 3-year overall survival for patients with BTCs, and today at ESMO, we are also showing outcomes for the HIMALAYA in first-line unrespectable HCC with outcomes at the 5-year time, again, the first-ever seen for these patients, so really improving hope in the long-term setting.

Last but not least, we’re seeing a wave of our novel agents coming now with our bispecific. We have exciting data across both World Lung and ESMO, with two novel agents in our bispecific portfolio, one being our CTLA-4/PD-1 bispecific, and the second being our PD-1/TGIT bispecific. We hope to show you more data with those in the near future.

An important takeaway from the WCLC conference is also the importance of the perioperative regimen in general for patients with early-stage resectable non-small cell lung cancer. Seeing the data showing that perioperative patients really benefit more than patients who receive neoadjuvant therapy alone really sets the stage for the importance of the AEGEAN regimen and the benefit we really hope to add to patients with this early-stage disease.

At AstraZeneca, our bold ambition is to eliminate cancer as a cause of death by 2030.

What’s really exciting about the data that we’re seeing this year, and importantly, at this ESMO, is we’re getting one step closer to data readout. We’ve had data readouts across multiple modalities this year, and really importantly, we’re announcing data coming out of our next wave of immunotherapy agents – the bispecific. I look forward to the potential for these agents to transform outcomes for patients across multiple tumor areas.