AKESO shared for the first time the global survival data of a high-level Keytruda head test for its Ivonescimab bispecific Ivonescimab PD-1XVEG-and investors in the partner of the company Summit Therapeutics do not take the result too well.
The Summit Summit equity rate on the NASDAQ fell by almost 37% after AKESO’s revelation before the implementation of a negotiation intervention.
Friday, by announcing (Chinese) (Chinese) Ivonescimab in lung cancer non-small PD-L1-L1-L1-L1 cells, Akeso noted that the bispecific drug had reduced the risk of death by 22.3% compared to Keytruda during a provisional analysis of the Harmoni-2 test looked closely.
The number apparently did not cross the statistical significance bar, which had an alpha assignment of 0.0001. The analysis was carried out when 39% of the predefined deaths for the final analysis were recorded.
Chinese approval was based on data showing that Ivonescimab has reduced the risk of increase or death by 49% compared to Keytruda in the Chinese trial. Patients who took medication Akeso lived an 11.14 -month -old median without progression of the disease, compared to 5.82 months for Keytruda.
The magnitude of the overall improvement in survival and non-compliance with statistical importance apparently disappointed Summit investors, who recently took advantage of a rally after Ivonescimab displayed another Chinese phase 3 victory, beating beigene pd-1 tevimbra de Beigène in their respective combinations without chemotherapy in the first line of the first line of stimulated thumbs cells.
To put into perspective the overall survival data of 22.3%, the various indications of Keytruda in the first -line NSCLCs are mainly based on reductions of 30% in addition to the risk of death compared to the control arms. The only exception is Keynote-042, which is exactly the same monotherapy, a positive PD-L1 as the Harmoni-2 test. In Keynote-042, Keytruda has only reduced the risk of death by 19% compared to chemotherapy.
Despite the dark reaction of the market, Citi Yigal Nochomovitz analyst, Ph.D., qualified the initial overall survival number a “excellent result”, noting that the statistical bar of 0.0001 was “extremely high”.
The 0.777 Hazard report is “solidly lower” with the 0.8 threshold quoted by most oncologists as clinically significant, said Nochomovitz in a note on Friday. A risk report of 0.8 results in a risk reduction of 20%.
Akeso has not shared the global survival curves, “which will provide very important clues to separation (global survival) that the singular number (risk ratio) cannot reveal,” noted Nochomovitz.
One thing that Nochomovitz has not articulated is that the small alpha allowance can suggest that HEESO spends much more alpha for a future analysis to give Ivonescimab a better chance to strike a statistical meaning on the overall survival potentially during the final evaluation.
However, some industry observers have expressed their concern about what with longer follow -up, the chances of respecting the statistical meaning are lower because subsequent therapies can the first line effect of Muddy Ivonescimab.
In the end, Harmoni-2 is a study only in China. Summit leads the Harmoni-7 trial, a global ivonescimab of phase 3 in Keytruda, in the front line NSCLC, in pd-l1 height. This test is well fed on global survival and “would have all the risk of likelihood the end of the operating system with a similar ~ 0.777 HR,” said Nochomovitz.
“We expect American doctors to seize the opportunity to treat the 1L-NSCLC PTS with a drug that offers a relative reduction in relative risk of ~ 22 to 23% on the standard Keytruda in current gold, supposed to be proven with statistical rigor in Harmoni-7,” he added.
