Summit Therapeutics SMMT is working to expand ivonescimab’s growth potential beyond non-small cell lung cancer (NSCLC), its lead development area. The company is advancing the investigational drug across several other cancer types, including colorectal and bladder cancer, to broaden its potential applications.
Alongside its internal development efforts, Summit is also collaborating with established pharmaceutical companies, including AstraZeneca AZN, GSK plc GSK and Arcus Biosciences RCUS, to evaluate ivonescimab in combination with other investigational and marketed cancer therapies.
Summit Advances Ivonescimab Into New Cancer Indications
Colorectal cancer is one of Summit’s most important internal development opportunities beyond lung cancer. In May 2026, a phase II study co-sponsored by Akeso, Summit’s China-based partner, showed promising results for ivonescimab combined with chemotherapy in previously untreated patients with unresectable metastatic colorectal cancer (mCRC).
Building on these findings, Summit is conducting the global phase III HARMONi-GI3 study, which compares ivonescimab plus chemotherapy with bevacizumab plus chemotherapy as a first-line treatment for unresectable mCRC. The study marks Summit’s first clinical program outside NSCLC to advance to phase III, representing an important step in the company’s efforts to expand ivonescimab’s development into additional tumor types.
Summit is also expanding ivonescimab’s development into urothelial carcinoma, the most common type of bladder cancer. The company recently initiated the global phase II/III HARMONi-GU1 study to evaluate ivonescimab in combination with Astellas Pharma and Pfizer’s Padcev (enfortumab vedotin) against Merck’s Keytruda (pembrolizumab) plus Padcev as a first-line treatment for advanced urothelial carcinoma.
The study will directly compare the investigational combination with an established treatment regimen. This approach could help determine whether adding ivonescimab’s dual-targeting mechanism provides additional clinical benefits in a competitive cancer treatment market.
SMMT's Partnerships Boost Ivonescimab’s Growth Potential
Beyond its internal clinical programs, Summit is using strategic collaborations to explore ivonescimab across a wider range of solid tumors.
Earlier this month, Summit's pipeline expansion received a boost from its strategic collaboration with AstraZeneca and Daiichi Sankyo. The companies plan to evaluate ivonescimabin combination with Datroway (datopotamab deruxtecan), a TROP2-targeted antibody-drug conjugate (ADC), across multiple solid tumors, including breast and lung cancers.The collaboration is expected to begin with a phase III study in first-line triple-negative breast cancer (TNBC), an aggressive form of breast cancer with significant treatment challenges.
The agreement builds on Summit’s broader collaboration with AstraZeneca announced last month to evaluate ivonescimab alongside sonesitatug vedotin (Sone-Ve), AstraZeneca’s investigational cancer therapy, in gastrointestinal cancers. As part of the broader agreement, AstraZeneca also committed to a $2 billion investment in Summit, providing substantial financial support for the company’s development strategy.
Earlier this year, Summit also partnered with Arcus Biosciences to evaluate ivonescimab with casdatifan for advanced kidney cancer, with initial data expected by mid-2027. Summit also partnered with GSK to assess ivonescimab in combination with its investigational B7-H3-targeted ADC, risvutatug rezetecan, across multiple solid tumors.
These partnerships provide opportunities to combine ivonescimab with other promising cancer medicines while sharing development responsibilities and costs.
The collaboration reflects Summit’s broader strategy of combining ivonescimab with therapies that target different cancer-related pathways. Such combinations could potentially improve treatment outcomes, although their clinical value will need to be established through studies.
Summit Maintains Its Focus on Lung Cancer
Besides expanding into other tumor types, Summit continues to prioritize lung cancer, which represents its most immediate potential path to commercialization in the United States. The FDA is currently reviewing an application seeking approval for ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment. A final decision is expected by Nov. 14, 2026.
A potential approval could give Summit its first commercial opportunity in the United States and establish an important foundation for the drug’s further development in lung cancer.
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