Traders Wobble On Merck KGaA After Stimuvax Stop
September 12, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Biopharma giant Merck KGaA saw its shares fall more than 8 percent on Friday after the company announced it had stopped all clinical studies of the experimental lung cancer vaccine tecemotide, formerly known as Stimuvax.
Licensed by Oncothyreon Inc. to German-based Merck seven years ago, Stimuvax had been touted as a promising treatment for patients with Stage III non-small cell lung cancer (NSCLC), but repeated trials on patients in Japan had not proved the drug’s effectiveness, the company said.
“The results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals. Therefore, we have decided to discontinue the development of tecemotide," said Luciano Rosetti, global head of research & development at Merck's biopharmaceutical division, in a statement.
Rosetti said Merck will instead refocus its efforts on other promising candidates in the pipeline, like our anti-PD-L1 antibody MSB0010718C. “We remain committed to developing new treatment options for patients with difficult-to-treat cancers,” he said.
The American Cancer Society estimates that around 85 percent to 90 percent of all lung cancers globally are non-small cell lung cancer, with three main subtypes adenocarcinoma, squamous cell carcinoma and large cell carcinoma. These subtypes differ in size, shape and chemical make-up but are grouped together because the approach to treatment and prognosis are similar.
The company’s decision to discontinue the current clinical program in NSCLC, which includes the Phase III START2 and INSPIRE studies, follows recent results from a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled Phase I/II study in Japanese patients with Stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose =50 Gy.
Of the patients included in the Phase II part of the study, the majority had received concurrent CRT.
“The results indicate that no effect has been observed for either the primary endpoint, overall survival (OS), or for any of the secondary endpoints (progression-free survival [PFS], time to progression [TTP] and time to treatment failure),” said Merck. “An analysis of the reported adverse events has not identified a clinically meaningful difference in the frequency between treatment groups.”