CHICAGO—Ready for ASCO? We are. With a wealth of oncology data slated to pour out over the weekend, here are a few of the studies we’ll be keeping closest tabs on.
- AstraZeneca is set to roll out details from a phase 3 trial that showed its PARP contender, Lynparza, could top standard-of-care chemo at increasing progression-free survival in patients with HER2-negative breast cancer and BRCA1 or BRCA2 mutations. It touted top-line results in February, putting some pressure on key PARP rival Tesaro.
- Just a few weeks ago, shares in Incyte leapt after the company reported positive results for its epacadostat—vying to be the first-in-class IDO1 inhibitor—alongside Merck’s PD-1 blocker Keytruda. This was a sneak peek first at the data from the mid-stage study, with the full low-down being held back for ASCO to show its potential as a “second generation” IO agent. The snapshot made for encouraging reading and bodes well for the prospects of inhibitors of IDO, which, like PD-1 is a pathway used by tumors to escape detection by T cells.
- Loxo Oncology will reveal on Saturday interim clinical data from all three ongoing larotrectinib (LOXO-101) tests. The Array Biopharma-partnered larotrectinib is a selective inhibitor of tropomyosin receptor kinase (TRK), a neuron-stimulating factor that is active in fetal development but has its expression switched off later in life. In some cases, the TRK gene can fuse with other genes and reactivate, causing various forms of cancer. Loxo's development program for the drug is agnostic to any particular solid tumor type, focusing instead on recruiting patients whose cancer cells express the TRK gene. That means that if approved the drug could be prescribed across multiple solid tumor types on the strength of genetic testing for neurotrophic TRK (NTRK) fusion proteins. And in fact, Roche just two months ago teamed up with Loxo to develop TRK immunohistochemistry test for this very purpose.
- Bristol Myers Squibb’s Opdivo and Yervoy are already approved as a tandem in melanoma. This weekend, investors will get a look at the combo as a treatment for mesothelioma, a rare form of lung cancer. The company will present phase 2 results pitting the duo against solo Opdivo.
- Johnson & Johnson will unveil data from a pair of trials adding its prostate cancer med Zytiga to first-line androgen deprivation therapy. One examined the treatment in newly diagnosed patients with high-risk metastatic prostate cancer, while the other looked at therapy for men with high-risk locally advanced or metastatic forms of the disease.
- Roche will reveal just how big a win its Perjeta came away with in the phase 3 Aphinity trial, which tested it alongside Herceptin and chemotherapy in early-stage patients with HER2-positive breast cancer. The Swiss drugmaker announced top-line results in early March, giving investors hope that a new indication for Perjeta could be on the horizon.
- Nanjing Legend Biotech is looking to set out a new-type of CAR-T cell therapy in relapsed/refractory multiple myeloma for LCAR-B38M in an early-to-midstage trial. Its ongoing trial is primarily set up to assess any treatment-related AEs, but secondary are anti-myeloma responses to the med.
- How did Pfizer’s dacomitinib, which has already flopped in two phase 3 studies, fare against AstraZeneca’s Iressa in a third phase 3 trial? That’s the question the New York drug giant will answer on Monday, when it presents results of the med as a treatment for EGFR-positive, advanced non-small cell lung cancer patients.
- Roche will delve into the head-to-head beating of Pfizer’s Xalkori that Alecensa posted this April in first-line, ALK-positive, advanced non-small cell lung cancer. The trial marked the second time in less than a year that Alecensa had triumphed over Xalkori, and the new results will add to its case for full approval in the front-line setting.