Every year tens of thousands of cancer researchers, doctors, investors and analysts travel to Chicago in early June for the annual meeting of the American Society of Clinical Oncology. It's the largest conference in the drug industry's hottest field.
Research at the conference often highlights progress from key clinical studies of cancer therapeutics, impacting the market fortunes of the drugmakers which make them.
After the close of the market yesterday, some 5,000 abstracts for studies set to be presented at the meeting were posted online. While the data contained within those study snapshots is incomplete, investors and analysts have taken to digging through the documents for clues as to how important drugs are performing.
Read on for five (early) takeaways of what to expect from ASCO when it kicks off in two weeks:
Case for immunotherapy plus chemo looks even stronger
While cancer immunotherapy has impressed with strong efficacy in some cancer types, too many patients still don't see a benefit.
In hopes of boosting the number who do, drugmakers across the industry have invested in studies testing combinations of immunotherapies with other drugs. Results have been mixed, as successes have come alongside setbacks.
What's become clear, however, is that combining immunotherapy with chemotherapy appears to be effective in driving further benefit. Merck & Co.'s Keytruda stands out in this regard, having won approval for treating non-small lung cancer (NSCLC) when combined with chemo.
But, as updates included in several ASCO abstracts suggest, rival drugs also appear to pair well with chemo in first-line NSCLC.
Bristol-Myers Squibb's Opdivo (nivolumab) plus chemotherapy drove a 26% reduction in the relative risk of progression-free survival versus chemo alone, data from an abstract of the pharma's closely watched CheckMate-227 trial shows.
Elsewhere, an abstract of Roche's IMpower-150 study detailed the overall survival benefit from a combination of the Swiss pharma's Tecentriq paired with chemo and the older cancer drug Avastin (bevacizumab).
Updates from several other key studies by Merck and Roche are still under wraps and will be revealed at the conference.
"We think the market in 1L NSCLC is becoming even more competitive as [Bristol-Myers] and Roche demonstrate comparable efficacy in their own combinations, and the role of PD-1/chemo combo is further consolidated with more positive data," wrote Leerink analyst Geoffrey Porges in a May 17 note.
Regeneron's cemiplimab stays on track
Five PD-1/L1 inhibitors are currently approved in the U.S., with Keytruda (pembrolizumab) and Opdivo far ahead of rivals.
The clinical and commercial success of the checkpoint blockers has sparked a frenzy of 'me-too' drug development, raising questions of where drugmakers looking to enter the market can make a mark.
Such doubts haven't stopped Regeneron from pushing forward with testing of its own PD-1 inhibitor cemiplimab, though. The biotech is aiming first at cutaneous squamous cell carcinoma (CSCC), an indication for which the other immunotherapies aren't approved.
Regeneron, and its partner Sanofi, presented positive data last December and submitted the drug for U.S. approval earlier this year. Data included in the ASCO abstract of the study revealed little new information, highlighting a roughly similar 47.5% response rate among CSCC patients.
For the first time, however, investors got a glimpse of the drug's efficacy in the more lucrative — but more competitive — lung cancer market. Early results from 21 patients in a Phase 1 NSCLC study showed treatment with the drug led to a 29% overall response rate. While good, that's not exactly a sign of market-beating efficacy.
"[Regeneron]'s cemiplimab looks like a PD-1 antibody, which it is," Evercore ISI analyst Josh Schimmer noted dryly in a May 16 note to investors.
Regeneron claims its drug will be third to market, not sixth, hypothesizing that blocking the PD-1 receptor rather than the PD-L1 ligand is more effective. Investors are still waiting for proof.
Investors aren't sold on Nektar combo just yet
In February, Bristol-Myers bet $1.85 billion on the promise of an experimental early-stage immunotherapy developed by Nektar Therapeutics, hoping to pair the drug with Opdivo. The companies plan to test the two drugs together across nine different cancers.
At ASCO, data from a Phase 1/2 study known as PIVOT will be presented for several solid tumor types — giving investors a more detailed look at what attracted Bristol-Myers to Nektar's compound.
Early signs from the abstract, which includes efficacy data from only 60 patients, raise some questions though. Response rates from the combo in melanoma and kidney cancer dropped a touch lower from previous updates.
Opdivo has already demonstrated benefit in these indications, so investors are looking for signs adding Nektar's drug yields a significant efficacy boost.
"We're still not convinced that NKTR-214 has been dosed to add meaningful incremental effect over PD-1 antibody alone — so will look towards the full dataset to better inform our perspective," Evercore's Schimmer wrote.
Worth noting, however, is the fact that 22 patients in the Phase 2 portion of the study had only one follow-up scan, meaning results could improve over time. Look to the conference itself for a clearer reading on whether Bristol-Myers' bet was well placed.
Loxo outshines rival in RET-mutant cancers
Loxo Oncology first captured investor attention at last year's ASCO meeting, presenting impressive data for its experimental drug larotrectinib in patients whose cancer expressed a rare genetic abnormality known as TRK fusion. The biotech has since parlayed that data into a $1.5 billion deal with German pharma Bayer.
Now, as ASCO approaches, investors will be focused on another pipeline drug known as LOXO-292.
Designed to treat cancers with a genetic mutation known as RET, the drug drove a 69% overall response rate among RET-positive patients with non-small cell lung cancer and a type of thyroid cancer, according to an abstract of the Phase 1 study.
Notably, no dose-limiting toxicities were observed and the drug appeared relatively well-tolerated, with no Grade 3 adverse events attributed to LOXO-292.
The results also appear to stack up well against data from Blueprint Medicine's rival candidate BLU-667, analysts noted. Shares in Loxo surged by nearly 20% in Thursday morning trading.
Jounce gets bounced by shaky data
Investors were less impressed with data from Jounce Therapeutics.
Shares in the Cambridge, Massachusetts-based biotech fell more than 30% Thursday as markets digested interim results from a Phase 1 study of the company's ICOS agonist JTX-2011.
Data included in the study abstract showed low response rates to the drug, given as monotherapy or paired with Opdivo in patients with gastric cancer and triple-negative breast cancer (TNBC).
Of seven gastric cancer patients given JTX-2011, only one saw a partial response. Among 19 patients given Jounce's drug with Opdivo, two experienced a partial response and two had ongoing stable disease. In TNBC, one partial response was reported in 15 patients given the combo.
Patients in the study were heavily pretreated and immunotherapy has not seen as much success in TNBC as of yet.
In a May 16 statement, the company sounded an optimistic note and indicated updated results would be presented at ASCO.