Key Upcoming Oncology Clinical Trial Catalysts

Summary

• Busy months ahead for Millennium (Takeda) and Novartis.
• Roche continuing to target first-line NSCLC.
• Bayer making a push into prostate cancer.

With cancer immunotherapies driving an explosion in oncology clinical trials, it’s becoming increasingly difficult to keep track of key clinical trial activity and potential catalysts. We've analyzed all oncology trials in clinicaltrials.gov and have identified the near term "high impact" trials. Here's a list of all mid-late phase (phase 2 or later), industry sponsored oncology trials with enrollment of at least 150 patients that have a primary completion date within the next three months:

Here are some key insights for upcoming clinical trial activity:

• Millennium Pharmaceuticals (Takeda Oncology, (TKPYY)) is set to have an active three months, with four “high-impact” trials expecting to reach primary completion by the end of May, and three of those in March alone. Novartis (NVS) also will be busy, with four trials of their own coming to primary completion in the next three months.
• LOXO Oncology (LOXO), the darling of ASCO last year, is expected to reach primary completion on its high profile NAVIGATE trial in April (NCT02576431). This trial is unique in that it enrolls patients with TRK fusions, regardless of cancer type. A rolling NDA submission for Larotrectinib was initiated in December of last year. The company expects to complete the submission in “early 2018.”
• One of the larger I/O-I/O combination trials, a phase 3 melanoma trial with Merck’s (MRK) Keytruda and Incyte’s (INCY) Epacadostat (NCT02752074), which has an enrollment target of >700 patients, is expected to reach primary completion in May. I/O-I/O combinations are the next frontier for immunotherapy, and this market remains a land-grab. Bristol-Myers Squibb (BMY) also has an upcoming I/O-I/O combination trial read-out in May for Opdivo-Yervoy in head and neck cancer (NCT02823574).
• Roche (OTCQX:RHHBY), which is quickly accelerating up the immunotherapy food chain, looks to add to their lung cancer arsenal with a Tecentriq-carboplatin-Abraxane combination in first line metastatic non-small cell lung cancer – one of the most coveted and competitive indications for drug makers.
• Bayer’s (OTCPK:BAYN) massive ~1,500 patient ARAMIS trial in non-metastatic castration-resistant prostate cancer (NCT02200614) is the largest trial coming to primary completion in the next three months. Bayer’s Darolutamide (ODM-201) would compete with Pfizer’s (PFE) Xtandi and Johnson & Johnson’s (JNJ) Zytiga for the multi-billion dollar prostate cancer drug market. However, this market is likely to face competition from generics in the near term.

To stay on top of trial developments, we’ve built an interactive timeline of oncology trials that can be filtered and segmented by sponsor, indication, therapy, trial phase, and key dates. You can access the interactive timeline tool here: Oncology Clinical Trial Timeline - DeciBio. The data in the tool reflects an extract of all trial information from clinicaltrials.gov as of 3/3. We will plan to update the timeline on at least a weekly basis going forward.

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Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Some of the companies mentioned may be DeciBio Consulting clients or customers.