For the second time in as many months, the lack of statistically significant overall survival data sent shares of Summit Therapeutics Inc. sliding, despite otherwise positive findings for PD-1/VEGF bispecific candidate ivonescimab in non-small-cell lung cancer. But analysts noted the stock reaction overlooks the consistency of the efficacy data to date, as well as the fact that the phase III Harmoni study marks the first pivotal trial testing ivonescimab in a global population.
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
Chinese pharmaceutical companies are making significant inroads into the global oncology market, particularly with the development and approval of immune checkpoint inhibitors. These treatments, which have shown strong efficacy in various cancer indications, are not only transforming the oncology landscape in China but are also gaining traction in high-value international markets, including the U.S.
Akeso Inc. has received IND approval by China’s National Medical Products Administration (NMPA) for AK-139, an IL-4Rα/ST2 bispecific antibody under investigation for a number of indications, including respiratory and skin diseases.
Miami-headquartered Summit Therapeutics Inc. expanded rights to Akeso Inc.’s non-small-cell lung cancer (NSCLC) drug, ivonescimab (SMT-112; AK-112), June 3 while raising $200 million to advance the therapy.
Specialised Therapeutics Asia Pte Ltd. has inked a $73 million deal with CTTQ-Akeso Biomed Tech. Co. Ltd. to buy the rights to commercialize the latter’s anti-PD-1 antibody in Australia and Southeast Asia.
Specialised Therapeutics Asia Pte Ltd. has inked a $73 million deal with CTTQ-Akeso Biomed Tech. Co. Ltd. to buy the rights to commercialize the latter’s anti-PD-1 antibody in Australia and Southeast Asia.
In a massive deal that is one of the year’s biggest, Akeso Inc. signed a collaboration and license deal with Summit Therapeutics Inc. to out-license its bispecific antibody, ivonescimab (AK-112), for development and commercialization in the U.S., Canada, Europe and Japan.
China’s National Medical Products Administration (NMPA) awarded Akeso Inc. breakthrough therapy designation for its PD-1 checkpoint inhibitor/VEGF bispecific antibody, ivonescimab (AK-112), combined with docetaxel for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients who failed to respond to prior PD-(L)1 inhibitors combined with chemotherapy.
