Cerulean crashes in PhIIb NSCLC study
This article was originally published in Scrip
The News in a Nutshell
Cerulean Pharma, based in Cambridge, Massachusetts, has missed its primary endpoint of overall survival benefit in a Phase IIb study of experimental cancer treatment CRLX101 in patients with advanced non-small cell lung cancer (NSCLC). The drug is a topoisomerase and hypoxia-inducible factor-1alfa inhibitor.
Primary Endpoint details
The trial's primary endpoints were median overall survival and safety and tolerability.
Secondary Endpoint details
Participants were additionally assessed for progression-free survival, objective tumor response and pharmacokinetic parameters.
Side Effects
Dr Edward Garmey, Cerulean's CMO said: “The safety profile for the treatment arm of this trial looks similar to the safety profile of the comparator arm. Importantly, most of the toxicities observed were grade 1 or 2 (low grade) with few grade 3 or 4 (more serious). The most common observations were anemia, fatigue, bone/joint pain, and shortness of breath, all of which are associated with the late-stage disease itself.”
Competition
As well as several marketed products, other drugs in development for NSCLC indclude:
- Lilly's Erbitux (cetuximab) and Boehringer Ingelheim's Tovok (afatinib), both filed for approval in the US and EU
- Gilead's Yervoy (ipilimumab), Bayer's Nexavar (sorafenib), GlaxoSmithKline's Evotopin (topotecan), Pierre Fabre's Javlor (vinflunine), Regeneron's Zaltrap (aflibercept), Eisai's Halaven (eribulin mesylate), Cell Therapeutics' Opaxio (paclitaxel), Merck KGaA/Oncothyreon's Stimuvax (emepepimut-S), all in Phase III trials
- 22 products in Phase II trials
Market size details
The NSCLC market is estimated to grow to $6.9 billion by 2019.
Next steps
CRLX101 is being studied in clinical trials in renal cell carcinoma in combination with Avastin (bevacizumab), and as a monotherapy in ovarian cancer, gastric cancer and small cell lung cancer. Data from the combination study will be presented at the American Association of Cancer Research annual meeting in April.
The company will analyze data from the NSCLC trial to inform further clinical development.
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