- Investors of NewLink Genetics Corp. appeared to have a change of heart for the company's lead candidate, indoximod, after updated results from a mid-stage study showed a stronger efficacy profile for the drug in combination with Merck & Co.'s Keytruda.
- Advanced melanoma patients treated with the combo had an overall response rate (ORR) of 61% and complete response (CR) of 20%, an improvement from previous data presented at the American Association of Cancer Research's 2017 conference that showed ORR of 59% and CR of 12%.
- Notably, 56% of participants receiving indoximod and Keytruda demonstrated progression free survival (PFS) at one year, while median PFS was 12.9 months. The positive data helped push up NewLink shares more than 40% on Thursday to trade at $13.60 by close of market.
NewLink's main challenge has always been showing its treatments can compete with those developed under rival drugmakers focused on indoleamine 2,3-dioxygenase (IDO)-inhibitors.
Chief among those rivals is Incyte Corp., which investors have flocked to over the last year. The Wilmington, Delaware-based company's stock is up more than 27% year-to-date and its market cap currently sits at around $26.4 billion.
Part of that increasing investment stems from Incyte's offering in the IDO space, dubbed epacadostat. Like NewLink, Incyte has investigated its drug in combination with big-name checkpoint inhibitors, including Keytruda (pembrolizumab) and Bristol-Myers Squibb Co.'s Opdivo (nivolumab), for a medley of cancer types. And so far it has done pretty well; data presented at the American Society of Clinical Oncology's 2017 conference showed that the combo of epacadostat and Keytruda had a 35% overall response rate in non-small cell lung cancer patients, a tougher treatment group.
The latest data for indoximod, however, reinforces the idea that the drug is just as effective as other therapies, if not more so.
Jefferies analyst Biren Amin, for instance, upgraded NewLink to a Buy rating in a Sept. 8 note, highlighting that the fresh data for the Keytruda and indoximod combo were "slightly better" than results from the mid-stage ECHO-202 trial testing a pairing of epacadostat and Keytruda also in melanoma patients. In that latter study, Incyte and Merck's combo had an ORR of 56%, a CR of 13% and a median PFS of 12.4 months.
Though "the baseline characteristics of the updated data showed a slightly healthier melanoma patient group in indox combo compared to epacado combo [in the] ECHO-202 study ... even adjusting for these suggests the data appear at least comparable to ECHO-202," Amin wrote in the note.
Incyte's stock fell a modest 1% on Sept. 7 to $134.34 per share, but dropped to $128.17 per share in Friday morning trading.
NewLink's Phase 2 study of indoximod tested the drug in combination with either Keytruda, Opdivo or Bristol's CTLA4 inhibitor Yervoy (ipilimumab). NewLink is now working on a pivotal Phase 3 trial evaluating its drug paired with either Keytruda or Opdivo for about 600 patients with stage three unresectable or stage four metastatic melanoma.
"Our team is excited to move forward with this pivotal trial," Eugene Kennedy, NewLink's head of clinical and medical affairs, said in a Sept. 7 statement. "We believe that allowing physicians the choice of either pembrolizumab or nivolumab accurately reflects current clinical care and should aid in enrolling the trial by the end of 2018."