With ivonescimab’s first phase 3 win outside lung cancer and a $2 billion investment from AstraZeneca in its U.S. partner Summit Therapeutics, Akeso CEO Michelle Xia, Ph.D., is expecting more combination opportunities for its star PD-1xVEGF bispecific.
Perhaps coincidentally, AstraZeneca’s strategic equity investment and clinical collaboration with Summit was formed about a month after ivonescimab beat the U.K. pharma’s Imfinzi in a head-to-head China phase 3 trial in biliary tract cancer—data that have now been shared at the European Society for Medical Oncology 2026 Congress.
In the Harmoni-GI1 trial, ivonescimab plus chemo cut the risk of death by 25% compared with Imfinzi and chemo for the first-line treatment of advanced biliary tract cancer. The Akeso combo improved median overall survival from the Imfinzi regimen’s 12.1 months to 14.9 months.
The magnitude of benefit may not be the largest in cancer research, showing that biliary tract cancer remains a tough nut to crack. Previously, Imfinzi and chemo became the new standard of care after conferring just a 20% survival advantage over chemo alone.
Any regimen that can improve overall survival is significant for patients, and the Harmoni-GI1 win is also significant for ivonescimab because it’s the drug’s first positive phase 3 beyond lung cancer, Xia said in an interview with Fierce.
“We have consistently believed from the very beginning that ivonescimab has a broad application because it’s scientific rationale is broad: PD-1 is broad, and VEGF is also broad,” she said.
The OS curves show clear separation between the ivonescimab arm and the Imfinzi arm. The PD-1xVEGF bispecific achieved the statistically significant improvement even as more patients in the control group received subsequent cancer treatment. The rates were 31.8% versus 45.9%, respectively.
What’s more, the ivonescimab regimen also significantly improved progression-free survival by 39%, with a median PFS of 8.4 months versus 5.8 months.
A global phase 2/3 trial sponsored by the ECOG-ACRIN Cancer Research Group is slated to test ivonescimab plus chemo in a global biliary tract cancer population.
Akeso moved ivonescimab into phase 3 in biliary tract cancer after seeing strong tumor response and survival data that compared favorably to historical PD-1/L1 results. Even so, taking on Imfinzi head-to-head was a “big decision” for the Chinese biotech, Xia said, not only because it would be challenging a standard of care but also because of the heavy financial input.
Now, with AZ on board, “money is no longer a concern,” Xia noted.
Xia called AZ’s investment “a very smart move” and a “win-win” because the money can be used to run trials, and the Big Pharma company can benefit from Summit’s upside. It also guarantees ivonescimab a partner for future combinations, she added.
To AZ, the last part is a big focus. In the first sentence of its announcement of the deal last month, AZ highlighted its intention to combine ivonescimab with its antibody-drug conjugates across tumor types. These include the CLDN18.2-targeted ADC sonesitatug vedotin, which also reports phase 3 data at ESMO 2026, and the Daiichi Sankyo-partnered TROP2 ADC Datroway.
“What that does is enable a broad swathe of collaborations across our portfolio, and I think that’s really key,” AstraZeneca’s oncology R&D chief, Susan Galbraith, Ph.D., said of the Summit deal in a separate interview with Fierce.
Galbraith put forward two factors that triggered the Summit deal. One is the “emerging maturity of data with ivonescimab,” and the other is “to maximize the potential for combinations with our ADCs.”
However, the structure of the deal—short of a licensing or acquisition—could also draw question to the depth of AZ’s commitment.
“Whenever we are doing partnerships, what we’re trying to do is both maximize opportunity and balance with the appropriate risk level across the setting,” Galbraith said. “We're encouraged by the data that we've seen with ivonescaimb, but again, drug development remains a risky business, and there are things that we want to see that will have risk unwind.”
AZ’s contribution is now transforming ivonescimab’s global clinical program into what Xia called “an upgrade version.”
In China, Akeso is conducting the Harmoni-BC1 trial pairing ivonescimab with chemo for the first-line treatment of triple-negative breast cancer. Now, AZ, Daiichi and Summit plan to start a global phase 3 in the same indication using Datroway as ivonescimab’s partner.
In the future, moving into earlier treatment settings and in combinations will be two key directions to advance ivonescimab, Xia said.
“A very important point is that ivo can become a combination partner with any product,” Xia said. “If you think immuno-oncology plays an important role in treatment, you cannot avoid partnering with ivo. Therefore, the potential is infinite.”