AstraZeneca has made a $2 billion strategic investment in Summit Therapeutics, pushing ivonescimab onto the center stage of global immuno-oncology competition. This deal not only serves as a major endorsement of the Chinese innovative drug's potential but also, at a time when Akeso's latest OS data has drawn widespread industry attention, further strengthens market expectations that ivonescimab can challenge the position of Keytruda.

On September 29, according to Reuters, AstraZeneca will subscribe to Summit preferred shares at a price equivalent to $18.36 per common share, representing an 18.6% premium over Summit's Monday closing price of $15.48, with the transaction expected to close within the week. Following the announcement, Summit's stock jumped more than 18% in after-hours trading. The two parties simultaneously announced they will jointly conduct a series of clinical trials to test ivonescimab in combination with AstraZeneca's cancer therapies, and have signed a preliminary agreement to explore combination regimens pairing ivonescimab with multiple AstraZeneca antibody-drug conjugates (ADCs).

The core asset in this transaction is ivonescimab, developed by Akeso (HKEX: 09926) and licensed to Summit in 2022 for a potential total deal value of up to $5 billion. It is the world's first PD-1/VEGF bispecific antibody. Analysts believe AstraZeneca's entry comes at a time window when ivonescimab has just released key overall survival (OS) data and once again defeated Merck's Keytruda in a head-to-head trial, carrying significant market signaling implications.

AstraZeneca's Heavy Bet Backs Ivonescimab with Top-Tier Pharma Endorsement

According to reports, AstraZeneca's $2 billion investment is a direct statement of confidence in ivonescimab's potential as a next-generation cornerstone of immuno-oncology therapy.

Ivonescimab's mechanism of action involves simultaneously blocking both the PD-1 and VEGF pathways—the former helps cancer cells evade immune system recognition, while the latter provides vascular support for tumor growth. Through dual blockade, ivonescimab aims to enhance the immune system's ability to recognize and attack cancer cells, offering potential mechanistic advantages over single-target PD-1 inhibitors.

As part of the collaboration, AstraZeneca and Summit will jointly initiate clinical trials testing combination regimens of ivonescimab with AstraZeneca's cancer therapies. The two parties have also signed a preliminary agreement to explore the combination potential of ivonescimab with multiple AstraZeneca ADC drugs—ADCs are a class of novel therapies that can precisely deliver cytotoxic drugs to tumor cells and currently represent a hot赛道 in global oncology drug development.

This transaction deeply binds AstraZeneca's R&D pipeline with ivonescimab, and also means Summit has gained heavyweight support in terms of funding and resources, which will help advance the subsequent development and commercialization of ivonescimab in the U.S. and European markets.

OS Data Again Surpasses Keytruda, Ivonescimab's Clinical Value Gains Key Validation

AstraZeneca's investment echoes Akeso's latest released ivonescimab OS data.

According to previous reports, on September 15, Akeso (HKEX: 09926) presented overall survival (OS) data from the HARMONi-2 clinical trial at the World Conference on Lung Cancer (WCLC). As of August 20, 2026, with a median follow-up of 36 months, ivonescimab's median OS was 30.8 months versus 22.6 months for Keytruda, reducing the risk of death by 27% and achieving pre-specified statistical significance with clear clinical benefit.

OS is regarded by the industry as the "gold standard" endpoint in oncology treatment. Ivonescimab had previously, on the strength of progression-free survival (PFS) data—median PFS of 11.14 months versus 5.82 months for Keytruda—first declared victory over Keytruda in May 2024. The release of this OS data further solidifies ivonescimab's clinical value.

The report noted that Mariana Brandão from the Jules Bordet Institute in Belgium, an on-site reviewing expert, stated that the benefit appears to be primarily driven by the PD-L1 high-expression population, and also unexpectedly by the squamous carcinoma population—squamous carcinoma typically has a poor prognosis but showed clear benefit in this dataset. She expressed excitement about the data but also pointed out that ivonescimab has higher toxicity than Keytruda, and there is currently a lack of biomarkers to predict which patients are more suitable for ivonescimab, so she would not immediately change clinical practice.

Mariana Brandão emphasized that the next key milestone is the global Phase III HARMONi-7 trial specifically designed for the PD-L1 high-expression population, the results of which will be decisive in determining whether ivonescimab can truly change clinical practice.

FDA Review Imminent, Overseas Commercialization Prospects Still Face Variables

Ivonescimab's globalization process is at a critical juncture, but uncertainties remain.

According to reports, in January 2026, the U.S. FDA accepted ivonescimab's marketing application based on the global multicenter Phase III clinical trial HARMONi, with the FDA's expected decision date set for November 14, 2026.

However, the HARMONi trial's data performance was not as impressive as HARMONi-2. In May 2025, Summit disclosed that the primary OS analysis of ivonescimab combined with chemotherapy in the HARMONi study did not reach statistical significance; although subsequent updated follow-up showed improvement in the OS hazard ratio, results demonstrating pre-specified statistical significance have not yet been disclosed.

At this WCLC, Summit updated the HARMONi data, stating that in the Western patient population, patients in the ivonescimab group continued to improve with extended follow-up, demonstrating cross-regional consistency, but the persuasiveness of the complete data still requires further observation.

For Akeso (HKEX: 09926), the overseas launch of ivonescimab is the core pathway to obtaining excess returns. In the first half of 2026, Akeso (HKEX: 09926) achieved revenue of approximately 1.8 billion yuan, a year-on-year increase of 27.92%, mainly supported by domestic sales of two core products, ivonescimab and cadonilimab.

Analysts believe that a breakthrough in overseas markets still depends on FDA review results, overseas clinical development progress, and the competitive landscape in the same therapeutic area.

Keytruda's Position Challenged, Next-Generation Immunotherapy Landscape Yet to Be Determined

Ivonescimab's rise directly targets the market position of Merck's Keytruda (pembrolizumab).

Keytruda is currently the cornerstone drug of immuno-oncology therapy, holding the title of global "drug king" in 2023 and 2024, with sales of $31.68 billion in 2025. Akeso (HKEX: 09926) positions ivonescimab as the next-generation cornerstone immuno-oncology drug after Keytruda.

Ivonescimab is the world's first drug to surpass Keytruda in both PFS and OS—two core endpoints—in head-to-head clinical trials, a record that has kept it in high focus among industry participants and investors. AstraZeneca's $2 billion investment further pushes this competition into the spotlight.

However, from clinical data to regulatory approval and then to large-scale commercialization, ivonescimab still faces multiple challenges: the OS data from the global HARMONi trial has not yet reached statistical significance, efficacy data in Western patient populations still needs to accumulate, and the improvement of toxicity management and patient selection tools will take time.

AstraZeneca's entry provides strong endorsement for ivonescimab's globalization, but whether it can ultimately shake Keytruda's market position remains to be revealed by the FDA review results in November 2026.