End of line for BMS, Nektar’s bempegaldesleukin/Opdivo alliance –
Four years after Bristol-Myers Squibb paid $1.85 billion up front to make Nektar’s bempegaldesleukin a companion drug to its Opdivo cancer immunotherapy, the alliance is on hiatus.
Things already looked shaky for the program last month when a Phase 3 trial of the pegylated IL-2 drug bempeg given in combination with the PD-1 inhibitor Opdivo (nivolumab) as a first-line treatment for melanoma got under way. failed at all levels.
Now, with two other pivotal trials in renal cell carcinoma (RCC) and urothelial carcinoma (UC) also failing, the two partners have chosen to halt all studies of the combination.
The previous PIVOT IO-001 study in melanoma showed no benefit of bempeg over Opdivo alone, and in the PIVOT-09 study in patients with previously untreated advanced or metastatic RCC, Opdivo/ bempeg was no better than a tyrosine kinase inhibitor control arm.
Meanwhile, Phase 2 PIVOT-10 twinning in UC “has not reached a threshold of effectiveness to support the continuation of the program”, according to the partners.
A pivotal trial of the combination in muscle-invasive bladder cancer, as well as early-stage studies in front-line RCC and pediatric tumors, are being halted.
The result was well reported by Nektar after the melanoma study was read, after which chief executive Howard Robin said the setback would lead to “substantial” changes to the company and its business operations.
BMS had pledged up to $3.6 billion in milestones and covered much of the development costs under the partnership.
The disappointing results are also a blow to Merck & Co, which tested bempeg alongside its PD-1 inhibitor Keytruda (pembrolizumab) in patients with non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN ).
If bempeg is completely discontinued, Nektar will end up with two other pegylated cytokine candidates – NKTR-255 (based on IL-15) for cancer and NKTR-358, an IL-2 T reg cell stimulator in partnership with Eli Lilly for inflammatory conditions like lupus and atopic dermatitis, both of which are in early to mid-stage clinical testing.
The company still had significant cash reserves of around $730 million at the end of last year, which it says is enough to keep it operational until the end of 2024 – giving it time to read the NKTR-255 and NKTR-358 programs. .
Nektar said it is preparing a new strategic plan to save money which will be revealed before the release of its first quarter results.