Nektar confirms BMS deal for NKTR-214 is on track

Nektar Therapeutics has said the company’s $3.6bn deal with Bristol-Myers Squibb for immuno-oncology drug NKTR-214 won’t be affected by the big pharma’s acquisition of Celgene.

In an update at the JP Morgan Healthcare conference in San Francisco yesterday, CEO Howard Robin said that the two partners are on track to start two new phase 3 studies of NKTR-214 in front-line and second-/third-line non–small-cell lung cancer (NSCLC) in the second-quarter, and are now working on 20 indications across nine tumour types.

Analyst Andy Hsieh at William Blair said the update “soothes investor concerns regarding the level of commitment to NKTR-214 as the partner refines its lung cancer strategy while in parallel works toward closing the merger with Celgene”.

Robin said that studies are now underway for the CD122-biased agonist in small cell lung cancer (SCLC), breast cancer, colorectal cancer, gastric cancer, and sarcoma, adding to the previously-disclosed studies in melanoma, renal cell carcinoma (RCC), bladder, and NSCLC. Additional trials in indication such as triple-negative breast cancer (TNBC) are also planned.

Nektar disclosed phase 3 data from the PIVOT trial of NKTR-214 plus BMS’ PD-1 inhibitor Opdivo (nivolumab) at the ASCO meeting last year, although the two companies were forced to defend the results and what seemed to be dip in response rates from an earlier readout.

BMS’ commitment to the programme seems assured given the number of new studies coming down the pipe, and amongst these “lung cancer is the highest priority for the collaboration” said Robin at JPM2019, adding that “this is one of the broadest…development programmes for any oncology drug.”

He also revealed that Nektar has agreed to test NKTR-214 with Pfizer’s PD-L1 inhibitor Bavencio (avelumab), PARP inhibitor Lorbrena (lorlatinib) and anti-androgen drug darolutamide in indications outside the scope of the BMS alliance. Combination trials in head and neck cancer and castration-resistant prostate cancer will start later this year. Takeda is also a partner and will look at combining NKTR-214 with TAK-659, a dual SYK/FLT-3 inhibitor.

The update seemed to lay to rest investor concerns that the Celgene deal would lead to NKTR-214 being sidelined, and shares in Nektar rose 10% in the wake of the presentation.

“We continue to believe in the disruptive potential of NKTR-214 as the compound progresses to pivotal studies across various tumour types,” said Hsieh, who also noted that the company has $1.92bn in cash to bring NKTR-214 and its other development programmes forward.

Almost forgotten among the interest in Nektar’s immuno-oncology pipeline – which also includes three other candidates in clinical trials – is NKTR-181, a first-in-class, abuse-deterrent opioid analgesic that is due for an FDA verdict by 29 May.

It’s a measure of the excitement about Nektar’s cancer immunotherapy assets that Robin conceded that is not the highest priority for the company now – even though it has been fast-tracked by the FDA. The drug promises to deliver pain relief without the risk of addiction seen with other opioids, potentially helping to address the epidemic of opioid abuse currently gripping the US.