NewLink inks deal with AstraZeneca to test Imfinzi combo
September 28, 2017

Dive Brief:

NewLink Genetics Corp. has hooked up with AstraZeneca plc to study the safety and efficacy of combining its small molecule IDO pathway inhibitor, indoximod, with the British pharma’s anti-PD-L1 antibody Imfinzi in metastatic pancreatic cancer.
Through a three-arm, mid-stage study, the companies will assess the combo treatment plus standard of care chemotherapy compared to standard of care alone or standard of care plus Imfinzi.
The drugmakers will split funding for the study, and NewLink will act as sponsor. The Iowa-based biotech said it doesn’t expect the trial expenses to have any meaningful effect on its financial position, but didn’t give any additional financial details of the deal in a Monday statement.
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Dive Insight:

Combination therapeutics have long been an approach to better treat cancer, aimed at improving outcomes by tackling different pathways. Advances in immuno-oncology have sent this strategy into overdrive, as drugmakers look for new ways of broadening the efficacy of checkpoint inhibitors. IDO inhibitors, such as NewLink’s indoximod or Incyte Corp.’s epacadostat, are seen as a potentially safer add-on therapy to PD-(L)1 blockers than anti-CTLA4 treatment.

Interim data presented last year looking at the combination of indoximod and Abraxane (protein-bound paclitaxel) showed the combination was well-tolerated, with a 45% overall response rate in the 31 patients investigators were able to evaluate. NewLink also reported signs of early and delayed durable responses — suggesting an immune-mediated mechanism.

The company now hopes to expand on this promise by exploring potential combinations.

“As recent data have indicated, indoximod combinations with immunotherapy and chemotherapy show promise of improving outcomes for patients with multiple tumor types,” Charles Link, NewLink’s CEO, said in the Sept. 25 statement.

AstraZeneca has made cancer combinations a central focus as it works to grow its Imfinzi (durvalumab) franchise. The drug gained accelerated approval from the Food and Drug Administration earlier this year in previously-treated patients with advanced bladder cancer, yet hit the market well after other immuno-oncology treatments from rivals Merck & Co., Bristol-Myers Squibb Co. and Roche AG.

To help catch the competition, AstraZeneca is trying to quickly rack up new indications. It is already carrying out combo studies with Imfinzi, pairing it with the anti-CTLA4 drug tremelimumab, for example, in non-small cell lung cancer — a highly competitive market for the PD-/PD-L1-targeting therapies. Should such investigations pan out, the combo approach could increase Imfinzi’s profile and profitability.

But the failure of Imfinzi plus tremelimumab to improve progression-free survival in the closely watched MYSTIC lung cancer study has dented AstraZeneca’s hopes of quickly catching its competitors.

AstraZeneca has also retrenched in pancreatic cancer, ending last year a Phase 3 study of Imfinzi with tremelimumab in first-line metastatic pancreatic ductal carcinoma.

Source: BioPharmaDIVE

Related: AstraZeneca Shows That With Immune Cancer Drugs, No One Knows What’s Next