Nektar to test bempegaldesleukin with Merck & Co.'s Keytruda in SCCHN trial

Nektar Therapeutics on Wednesday announced a clinical trial collaboration and supply deal with Merck & Co. to launch a Phase II/III trial testing the investigational CD122-preferential IL-2 pathway agonist bempegaldesleukin (bempeg) in combination with Keytruda (pembrolizumab). The study, which is slated to get under way in the second half of 2021, will evaluate bempeg together with Merck's PD-1 inhibitor as a first-line treatment for certain patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN). Shares in Nektar gained as much as 13% on the news.

Chief R&D officer Jonathan Zalevsky highlighted earlier combination studies of bempeg, formerly NKTR-214, plus immune checkpoint inhibitors (ICIs) showing "the potential to increase and deepen treatment responses as compared to historical rates for ICIs alone" in patients with immune-sensitive cancers.

In the randomised Phase II/III study, which will be conducted by Nektar, an estimated 500 patients with metastatic or recurrent SCCHN whose tumours express PD-L1 with a combined positive score (CPS) of 1 or greater will receive Keytruda, either alone or together with bempeg. The Phase II portion of the trial will include an interim analysis of overall response rate (ORR) on the first 200 patients who have had a minimum four months of follow-up. If it succeeds in passing a pre-specified futility boundary, the remaining 300 patients will be recruited into the late-stage portion, with patients to be split into those same two groups. The primary endpoints are ORR and overall survival, while progression-free survival will be assessed as a secondary goal.

New checkpoint inhibitor combo

The deal opens up bempeg to a new checkpoint inhibitor, as Bristol Myers Squibb, which markets Opdivo (nivolumab), has been Nektar's most notable partner until now. In 2018, the pair signed a global deal centred on bempeg potentially worth over $3.6 billion, including an upfront payment of $1 billion by Bristol Myers Squibb. As part of the collaboration, the companies agreed to jointly develop and commercialise bempeg in combination with Opdivo as well as Bristol Myers Squibb's Yervoy (ipilimumab) in more than 20 indications across nine tumour types.

The joint programme for bempeg plus Opdivo includes registrational and other studies in melanoma, renal cell carcinoma and bladder cancer. However, Nektar is still allowed to develop its drug with other checkpoint inhibitors in tumour types not covered by the Bristol Myers Squibb deal.

Separately on Wednesday, Nektar also announced a financing and co-development collaboration with SFJ Pharmaceuticals that will help support the bempeg combination trial with Keytruda. Under the terms, SFJ agreed to fund up to $150 million to support the Phase II/III study and manage clinical trial operations.

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