May 31, 2017
By Karl Thiel for BioSpace.com
We are at the climax of the clinical calendar, at least if you’re interested in oncology: ASCO kicks off this Friday, and the biotech industry is already abuzz about new data being released upon the world. This is a big meeting with a lot going on. But some presentations are more likely than others to move markets, spark conversations, and influence clinical practice. Here’s a guide to some of the data most likely to draw attention at the annual meeting.
Checkpoint inhibitors + anything
If there’s one over-arching theme to ASCO, it’s the PD-1 inhibitors—Keytruda (Merck, , Opdivo (Bristol-Myers Squibb, and, to a lesser extent, Tecentriq (Roche, . That’s been true for the past couple years, but now there is a lot more focus on combining these immuno-oncology drugs with other novel therapeutics, and a lot more data to look at. We’ve seen that these drugs can work wonders, but also that they are far from infallible. Thus, expect a lot of focus making a whole that it greater than the sum of its parts.
IDO inhibitors
It is hoped that these drugs could be the next frontier in immune-oncology. Indoleamine 2,3-dioxygenase (IDO) is a protein that suppresses the immune system and can sometimes be hijacked by tumors to fend off the body’s defenses. And naturally, many studies are looking at how these may work in tandem with checkpoint inhibitors. Two companies, NewLink Genetics and Incyte Pharma . are being closely watched for their IDO drugs. These are indoximod and navoximod for Newlink (the latter in partnership with Roche), and epacadostat for Incyte. Indiximod and epacadostat have already produced compelling data in melanoma, and there will be further details at ASCO. Navoximod will have early but closely-watched data in multiple solid tumors, including NSCLC, renal cell cancer (RCC), bladder cancer, and triple negative breast cancer. Incyte’s ASCO abstracts on epacadostat, particular where it was combined with Keytruda, excited the market when they were released.
Bladder cancer
There have been a slew of recent developments in urothelial carcinoma, aka bladder cancer. On the negative side, Roche came out this month with the surprising news that its checkpoint inhibitor Tecentriq failed to extend overall survival as a second-line treatment, despite having received a first-line approval in April. So what comes next? Keytruda is facing an approval decision on June 14 with some fairly solid data in hand. Opdivo is already approved for this cancer as a second-line therapy, but like Roche, it must confirm the benefit in an ongoing trial. Still it will mostly be taking a victory lap at ASCO, presenting quality of life data from the CheckMate 275 trial.
Merck KgaA and Pfizer will be presenting phase 2 data on its PD-L1 inhibitor Bavencio (avelumab) as a second-line treatment—for which it just received approval earlier this month. (They will also present some highly anticipated data on Bavencio in Merkel cell carcinoma, where the drug just gained an approval in March). AstraZeneca ‘s Imfinzi was also approved this month as a second-line bladder cancer therapy and will be presenting closely watched data.
Just to round things out, Incyte has some intriguing and never-before-seen data in bladder cancer with IDO inhibitor epacadostat plus Keytruda. And Seattle Genetics will be presenting phase 1 data on ASG-22ME, its antibody-drug conjugate targeting Nectin-4.
Hematology
This is a big subject, but one closely watched area will be the CAR-T drugs. Bluebird , Kite , and Juno all have new data to report, but they are keeping us in suspense—released abstracts didn’t contain the new data that will only be revealed at the meeting itself. There, we’ll hear interim data on Bluebird’s bb2121 in multiple myeloma and new data on Juno’s JCAR017 in lymphoma. Both these programs are partnered with Celgene . We’ll also hear more about Kite’s KTE-C19, currently pending approval for non-Hodgkin lymphoma. Notably, Novartis won’t be presenting new data from the JULIET trial on its CAR-T therapy, CTL019—that will be released a few days later at the International Conference on Malignant Lymphoma in Switzerland. And a dark horse could show up in the way of Nanjing Legend Biotech, which has a late-breaking abstract on its anti-BCMA CAR-T, similar to Bluebird’s bb2121.
One area where the market has already seen new data is for AG-221 (enasidenib), the AML drug from Agios Pharmaceuticals and Celgene awaiting an August 30 approval decision. New data to be presented at ASCO shows an improved tumor response rate but a shorter duration of response versus data presented in December 2015. That will likely get a lot of scrutiny.
Non-small cell lung cancer (NSCLC)
Checkpoint inhibitors have already made big in-roads in NSCLC, but are still generally considered second-line therapy (outside of squamous cell and adenocarcinoma). And one big specter hanging over the field is the failure last year of Opdivo to improve progression-free survival in first-line lung cancer. That disappointment for BMS was capped this month when Keytrdua won approval as part of a combination therapy for first-line NSCLC, succeeding where Opdivo failed. But the story is hardly over.
In addition to the IDO inhibitors discussed above, one closely watched area is ALK (anaplastic lymphoma kinase) inhibitors. Alunbrig (brigatinib) received accelerated approval at the end of April for ALK-positive NSCLC, justifying Takeda’s recent $5.2 billion acquisition of Ariad . Xcovery apparently won’t be reprising recently presented data on its ALK drug ensartinib, but Pfizer will have data on lorlatinib, which was just granted breakthrough designation at the end of April. Other closely watched data will include EGFR-positive lung cancer, where AstraZeneca’s Tagrisso gained full approval at the end of March and new combination data will be presented. AstraZeneca’s Iressa for preventing NSCLC recurrence will also be closely watched.
Naturally, there’s a lot more going on than this, and there can always be surprises that crop up at the last moment. Here’s hoping for good news in Chicago!
-Karl Thiel
Read the BioPharm Executive online newsletter May 31, 2017.
Sign-up for the free monthly subscription to the BioPharm Executive
