Akeso Pharmaceuticals and Summit Therapeutics have reported that their PD-1/VEGF bispecific antibody has met the primary endpoint in a Phase III trial in patients with squamous non-small cell lung cancer (NSCLC).
The HARMONi-6 trial (NCT05840016) showed Akeso and Summit’s Idafang (ivonescimab), a programmed cell death protein 1 antagonist and vascular endothelial growth factor inhibitor, plus chemotherapy to be clinically and statistically more effective than BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab) plus chemotherapy in improving progression-free survival (PFS), the trial’s primary endpoint. The PFS benefits were clinically meaningful in both PD-L1-positive and PD-L1-negative populations.
Go deeper with GlobalData
The trial, conducted across 66 sites in China, enrolled 532 patients, approximately 63% of whom had centrally located squamous cell carcinoma, which the companies say is a distribution consistent with real-world patient populations.
While the companies have not announced the full data from the study, they say detailed results will be presented at an upcoming medical conference later this year.
Idafang demonstrated a favourable safety profile, with no new safety signals identified, with the companies noting that the incidence of treatment-related serious adverse events (AEs) and serious bleeding events were comparable between both groups.
Following the announcement, Summit’s stock, listed on the Nasdaq exchange, rose 21.49% in trading yesterday (23 April) while Akeso’s stock, listed on the Stock Exchange of Hong Kong (HKSE) is up 13.12% at market close today compared to market close on 22 April.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSummit acquired rights to Idafang in December 2022, in a deal with Akeso worth up to $5bn to co-develop Idafang. Akeso has out licenced the drug to Summit for development and commercialisation in the US, Canada, Europe and Japan while it retained the rest of the global market including China.
Previous success over Keytruda
Previously, the drug has shown benefit over Merck’s flagship drug Keytruda (pembrolizumab) in a head-to-head comparison in the HARMONi-2 trial (NCT05499390). The company announced the trial met its primary endpoint in May 2024 before presenting data at the World Conference on Lung Cancer (WCLC) in San Diego in September 2024.
The data showed that Akeso and Summit’s drug extended PFS to slightly more than a median of 11 months, compared to nearly six months for patients treated with Keytruda, translating into a statistically significant 49% reduction in the risk of cancer progression or death.
Previous positive data from Idafang, including its success over Keytruda, got Pfizer interested, with Summit and Pfizer having now forged a partnership to investigate Idafang in combination with several of Pfizer’s antibody-drug conjugates (ADCs).
Despite the amount of positive data which led to the approval of Idafang in China in May 2024, unless the companies run multi-country trials, including at US sites, it is unlikely the drug will receive approval from the US Food and Drug Administration (FDA). As a result, the companies are running the multi-regional Phase III HARMONi-3 trial (NCT05899608) and are setting up the HARMONi-7 trial (NCT06767514).
GlobalData predicts that Keytruda sales will peak in 2027, hitting $36.1bn, likely due to the 2028 patent expiration for the drug. Meanwhile, GlobalData predicts Idafang will hit blockbuster status in 2029, with 2030 sales set to reach $1.62bn.
GlobalData is the parent company of Clinical Trials Arena.
