Most drug licensing deals with China will be safe from rules being drafted by the U.S. Treasury Department, Reuters reports. Akeso and Summit Therapeutics' ivonescimab, B7-H3 antibody-drug conjugates and a surprise negative overall survival trend from Enhertu headlined WCLC26. Plus more.
1. US weighs allowing most pharma licensing deals with China, sources say (Reuters)
The U.S. Treasury Department is working on rules that would allow most licensing deals for Chinese drugs, Reuters reports, citing three people who have been briefed on the process. The rules are likely to allow U.S. companies to continue buying new drug candidates from Chinese companies as long as they are not related to pathogens or technologies that could be weaponized, the sources reportedly told Reuters. Lawmakers hawkish on China have asked the Treasury to crack down on biopharma transactions with China under the COINS Act.
Ivonescimab’s detailed head-to-head overall survival win against Keytruda revealed a 27% benefit in first-line, PD-L1-positive non-small cell lung cancer in the China phase 3 Harmoni-2 trial. The Akeso-Summit PD-1xVEGF bispecific prolonged median OS by 8.2 months to 30.8 months. The drug showed especially strong results in PD-L1-high patients, lowering the risk of death by 42% versus Merck’s PD-1 inhibitor.
3. GSK’s Hansoh-partnered ADC lays down marker for lung cancer scrap with Merck
Roche, MediLink notch phase 3 lung cancer win but trail GSK on cross-trial survival
The B7-H3 antibody-drug conjugate race is heating up among Chinese assets licensed to Big Pharma. GSK’s Hansoh-partnered ris-rez achieved a median OS of 18.5 months in a China phase 3 small cell lung cancer trial in previously treated patients. Roche’s partner MediLink reported a median OS of 12 months for their candidate, tam-peli, in a separate second-line SCLC trial in China. Cross-trial comparisons should be viewed with caution.
4. Increased deaths shadow AstraZeneca, Daiichi’s Enhertu first-line lung cancer data
In a rare setback for AstraZeneca and Daiichi Sankyo’s Enhertu, the star HER2 ADC showed a negative OS trend against Keytruda plus chemotherapy in first-line, HER2-mutant NSCLC. While the phase 3 Destiny-Lung04 trial met its progression-free survival endpoint, an interim OS analysis found that patients in the Enhertu arm lived a median 29.3 months, versus 33.1 months in the control arm.
5. Legend Biotech names Novartis veteran Ingrid Zhang as new CEO
Legend Biotech has named Novartis’ former China head, Ingrid Zhang, as its new CEO. Zhang, who most recently served as chief commercial officer for Novartis’ ex-U.S. business, succeeded interim chief Alan Bash, who has resumed his role as president of Carvykti. In a LinkedIn post shortly before the announcement, Zhang said patient access has “shaped how I’ve led.”
6. GSK doubles down on Chimagen with $750M multiple myeloma wager
GSK licensed a trispecific T-cell engager from China’s Chimagen Biosciences for up to $750 million. The disease is multiple myeloma, but the three targets were not disclosed. The program is expected to enter clinical testing in 2027.
Other News of Note:
7. Merck, Gilead’s failed Trodelvy lung cancer trial shows better China results
8. BioNTech sets survival standard in hard-to-treat cancer ahead of pivotal readout
9. Cullinan, Taiho showcase 6-month survival benefit in phase 3 trial for advanced lung cancer
10. BMS, Ono take Amgen to task as FDA's Opdivo biosimilar decision looms
11. SK pens $315M pact with fellow South Korean company for Parkinson’s prospect
12. AZ, Daiichi's Enhertu scores long-awaited NICE blessing in HER2-low breast cancer