Pharmaceutical Business review

OncoGenex to begin Spruce clinical trial to evaluate lung cancer agent

The randomized, Phase 2 study sponsored by SCRI will evaluate if the addition of OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival (PFS) outcomes.

The study primary investigator and Sarah Cannon Research Institute (SCRI) lung cancer research program director David Spigel said majority of patients do not have specific markers for targeted therapy and will still receive broad-spectrum treatments, like chemotherapy.

"There is an urgent need to improve upon outcomes for these patients," Spigel added.

"By targeting Hsp27 with an innovative therapy like OGX-427, we hope we can delay or prevent treatment resistance and extend the overall survival benefit currently provided by chemotherapy."

Around 155 patients with non-squamous NSCLC will be randimized with either OGX-427 plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy.

Maintenance therapy with pemetrexed and/or OGX-427/placebo will be continued in patients until disease progression or unacceptable toxicity.

PFS is the primary objective while the additional analysis will include evaluation of tumour response rates, overall survival, safety, tolerability, and the effect of therapy on heat shock protein 27 levels.