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 actually San Diego and now Esztero, 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 of 30 state 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 in the new adjuvant study in chemotherapy, and then in the adjuvant study post-surgery, we’re going to show an important benefit in EFS and OS with an enforced PCR. This is actually consistent with other perioperative studies set out, including updated data that we recently shared for lung cancer in the early non-small cell lung cancer perioperative study. We also had neoposturing that was building up on the Eugene backbone, with additional modalities in the new adjuvant study.

We’re awaiting further readout from the Matador study, which is our perioperative study in gastric cancer, where we’ve had PCR readout. So, we’re super excited about the evolution and the improvement in IMFINZI in perioperative setting with potentially curative intervention. NIAGARA is our global phase 3 study in the perioperative setting for muscle-invasive bladder cancer.

And fortunately, it’s the first phase 3 global study to read out, to demonstrate positive efficacy and safety results with adding chemotherapy to the perioperative setting. So, it is the addition of IMFINZI with standard immunotherapy in the neoadjuvant setting, and then post-surgery efficacy 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 additional efficacy in the adjuvant setting, we also see positive PFS with a hazard ratio of 0.68, and OS with a hazard ratio of 0.75 in the adjuvant 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 under intensity-plus-acute dose, or anti-PD-1 and our anti-CTLA-4 agents in the setting of first-line unrespectable patented biliary cancer or liver cancer. What’s really exciting about this data is it builds upon our legacy that long-term survival involves multiple indications, so now, for the first time ever, we’re seeing the hope of survival in 5 years for patients with first-line HCC.

Importantly, the HIMALAYA study looked at the combination of our anti-CTLA-4 agent from the Ipilimumab in one single priming dose with the addition of IMFINZI or anti-PD-1 agent on the 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 of patients to not only live to 5 years, but also have preservation of their liver. What’s really great about data across two conferences here, the World Lung Cancer Conference in San Diego and now ESMO NERVRIS, we’re really seeing an evolution of the goal that indemnifies them across multiple genotypes. In fact, this year alone, we’ve had 12 positive readouts, 7 indications in total from where we had 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 GEN study, including EFF, at the World Lung Conference.

We have read out here the first-ever perioperative regimen in musculovascular bladder cancer with the NIAGARA study, and recently at the former ESMO 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, as just a slightly.

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

Last but not least, we’re seeing a wave of our novel agents coming now with our bispecific. We have excited 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 WCRC conference is also the importance of the perioperative regimen in general for patients with early-stage effects of non-small cell lung cancer. Seeing the data showing that perioperative patients really benefit more than patients who receive the arginine therapy alone really sets the stage for the importance of the Aegean regimen and the benefits we really hope to add to patients with this early stage disease. At AstraZeneca, our bold ambition is to eliminate cancerous cause of death by 2030.

What’s really exciting about the data that we’re seeing this year, and unfortunately at this ESMO, is we’re getting one step closer to 3G data reading. We’ve had data readouts across multiple modalities this year, and really importantly, we’re seeing data coming out of our next wave of immunotherapy agents bispecific. I look forward to the potential for these agents to transform outcomes for patients across multiple genotypes.