Akeso PD-1 inhibitor cleared as Keytruda challenger advances

Hong Kong's Akeso has ended the week on a high note, with an FDA approval for its PD-1 inhibitor penpulimab and more data on PD-1/VEGF bispecific antibody ivonescimab.

Penpulimab has picked up a pair of approvals in nasopharyngeal carcinoma (NPC), becoming only the second drug to be cleared for treating the fairly rare form of head and neck cancer after Shanghai Junshi Biosciences' PD-1 inhibitor Loqtorzi (toripalimab), which reached the US market last year.

Akeso's antibody can be used as a monotherapy for adults with metastatic non-keratinising NPC with disease progression on or after platinum-based chemotherapy, after at least one other prior therapy, and in combination with chemotherapy (cisplatin or carboplatin and gemcitabine) for first-line treatment of recurrent or metastatic non-keratinising NPC.

It is the first approval for one of Akeso's internal pipeline of biologic drugs, although, penpulimab is already approved in China for similar NPC indications.

NPC is relatively rare in Western populations, but more common in Asia, and in most cases is associated with Epstein-Barr virus (EBV) infection. Keratinising forms of the cancer are thought to have a different pathology and are more common in the US than non-keratinising NPC.

"Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the US," said the company's president and chief executive, Dr Yu Xia.

The penpulimab approval came right on the heels of Akeso reporting new data with Summit Pharma-partnered ivonescimab, a drug that has already attracted considerable attention after besting MSD's best-selling PD-1 inhibitor Keytruda (pembrolizumab) in the HARMONi-2 trial in previously untreated, PD-L1-positive squamous and non-squamous non-small cell lung cancer (NSCLC).

Ivonescimab is already approved in China to treat EGFR inhibitor-resistant, advanced non-squamous NSCLC.

The new results from the HARMONi-6 trial come from a comparison of the PD-1/VEGF bispecific antibody in combination with chemo with BeiGene's PD-1 inhibitor Tevimbra (tislelizumab) plus chemo in squamous NSCLC and show that Akeso's drug "decisively beat" the rival regimen.

Details are scant at the moment but, according to Akeso, the results showed a "statistically significant and clinically meaningful" improvement with ivonescimab on the main endpoint of progression-free survival (PFS) in both PD-L1-positive and PD-L1-negative NSCLC.

The result "further positions ivonescimab to improve upon and replace the current standard of care for the treatment of NSCLC," said the company, while Dr Xia said it " demonstrated [ivonescimab's] breakthrough clinical value and market competitiveness as a next-generation cancer therapy."