Welcome to “Three Things in Biotech You Should Learn Today,” a digest of all things biotech. Investors in this field are always looking toward picking the one or two big winners before moving on, but this often leaves them a bit myopic with respect to other, actionable developments. I want to try and help you find the biggest bites every day that can add to your personal due diligence.
In volume 2 we’re rolling right along to start again with data from AACR, as it was an unusually strong year for this conference that tends to focus a little less on clinical science and a little more on basic research.
NewLink’s Slam Dunk in Melanoma Combo
NewLink (NASDAQ:NLNK) is one of several players developing additive treatments designed to bolster immunotherapy by targeting the indoleamine deoxygenase (IDO), which is made by tumors as another way of suppressing the immune system near the tumor cells. NLNK’s entry in this line is indoximod, and at AACR they demonstrated that addition of indoximod to Keytruda appeared to boost the response rate in patients with melanoma. In KEYNOTE-006 (which led to Keytruda’s approval in first-line melanoma), the response rate was 34%. The phase 1/2 combo study with indoximod yielded a response rate of 52%.
This places it just behind Incyte’s epacadostat as far as clinical development. The KEYNOTE-252 study is assessing the combination of Keytruda and epacadostat in a randomized fashion for patients with metastatic melanoma.
Looking forward: Almost a full year ago, NLNK’s pancreatic cancer trial failed, and the stock tanked dramatically. I wrote at that time that I felt this was an overcorrection based on their pipeline, and 2016 bore my hypothesis out, with recovery and reach over the period before the failed results. Now, they are closing in on what appeared to be Incyte’s game to lose, and they could represent an able competitor. Despite the beating NLNK has taken on these results, they do not represent a fundamental challenge to the company’s forward momentum, and I think this presentation at AACR bodes very well for the future of indoximod and NLNK.
Bristol-Myers jumps on the IDO Craze, too!
At AACR 2017, Bristol-Myers Squibb (NYSE:BMY) made its entry into the IDO space with a poster describing the pharmacodynamics and pharmacokinetics of BMS-986205 plus Opdivo in patients with advanced cancers. The combo appeared to be well tolerated, with lower doses (by weight) of BMS-986205 required to inhibit IDO (as measured by serum levels of kynurenine). No antitumor activity was reported for this agent, and BMY expects to initiate other clinical studies in the near future.
Looking forward: To be honest, this seems like a bit of a bizarre move, to me. While BMY might be able to leap into the fray with a drug that is possibly more potent, I look at these kinds of moves with skepticism. Too many times, “more potent” doesn’t pan out to “helps more patients” in solid tumors. And if the IDO inhibitors are going to make an impact on immunotherapy, then BMY will likely end up in, at best, third place with this new drug behind epacadostat and indoximod. Certainly, its entry into the fray could be better than the others, but this feels to me like a high-risk, low reward proposition in a field that will be highly crowded if the concept of IDO inhibition is proved correct.
Merck Confirms Activity of Keytruda in Head and Neck Cancer
On April 5, The Journal of Clinical Oncology published the findings of KEYNOTE-055, a phase II study designed to test the activity of Keytruda in patients with chemotherapy and Erbitux resistance.
Most of the patients (171 receiving Keytruda) had PD-L1-positive disease, and 22% were HPV-positive, as well. All patients were rather heavily pretreated, having undergone at least 2 prior lines of therapy. 16% of these patients responded, with most of those responses ongoing at the time of the data cutoff.
Looking forward: 16% response rate may not sound that high, but one needs to keep in mind the grim prognosis for these patients. With Keytruda, 16 out of 100 patients with no other options were kept alive, with manageable toxicity. Keytruda has already been approved in the head and neck space, for platinum-resistant disease. However, this approval is conditional based on follow-on studies to confirm the efficacy. Moreover, this is the first study to successfully show directly that Keytruda can help patients with prior treatment specifically on Erbitux+platinum therapy. While this is an iterative finding, it is important for uptake of Keytruda, and it will support future approvals in specific treatment lines, which is important for reimbursement by insurance and governments.
Thank you for tuning in. The immunotherapy space in oncology is evolving quick enough to make your head spin, and so many new findings are very hard to keep up with. If you liked this digest and would like to see more, please consider following me on Seeking Alpha, where you’ll get alerts when new articles of mine are released.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.