Date: 2014-09-12
Type of
information: Halting of the trial
phase: 3
Announcement: discontinuation of development
Company: Merck Serono, a Merck KGaA company (Germany)
Product: L-BLP25 - Stimuvax® (tecemotide)
Action
mechanism:
- immunotherapy product. L-BLP25 is an investigational MUC1 antigen-specific cancer immunotherapy that is designed to stimulate the body’s immune system to identify and target cells expressing the cell surface glycoprotein MUC1. MUC1 is expressed in many cancers, such as non-small cell lung cancer (NSCLC), and has multiple roles in promoting tumor growth and survival. L-BLP25 was being investigated in the Phase III START trial and is currently being investigated in the INSPIRE trial, both for the treatment of unresectable stage III NSCLC. Merck obtained the exclusive worldwide rights for development and commercialization of L-BLP25 from Oncothyreon in 2007, in an agreement replacing prior collaboration and supply agreements originally entered in 2001. In Japan, Merck entered into a co-development and co-marketing agreement for L-BLP25 with Ono Pharmaceutical.
Disease: unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC)
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
- The START2 study is a Phase III, multicenter, 1:1 randomized, double-blind, placebocontrolled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy (CRT). Concurrent CRT – a combination of chemotherapy and radiotherapy given at the same time – is the current standard of care for most of these patients. The study is expected to recruit about 1,000 patients. The study’s primary endpoint is overall survival (OS). Secondary endpoints include time to symptom progression, progression-free survival and time to progression.
Latest
news:
- • On September 12, 2014, Merck KGaA announced that its biopharmaceutical division Merck Serono will discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC).
- 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). An analysis of the reported adverse events has not identified a clinically meaningful difference in the frequency between treatment groups. Although the trial was not powered to demonstrate a statistically significant difference in benefit between the two arms, Merck Serono made the recommendation to stop the investigational treatment for patients in the EMR 63325-009 study in Japan. Merck Serono has made the decision to discontinue all other Merck Serono-sponsored clinical trials with tecemotide in NSCLC worldwide. Those patients on active treatment with tecemotide can undergo an individual assessment by their treating physician and apply to receive further treatment outside of the studies. The company will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with Merck’s agreements with the sponsors of these studies.
- • On April 7, 2014, Merck Serono has announced the initiation of the international Phase III START2 study, which is designed to assess the efficacy and safety of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). Merck received Scientific Advice from the European Medicines Agency (EMA) on the program, and reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the trial.
- • On September 25, 2013, Merck Serono has announced the decision to continue clinical development of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) under a new Phase III trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). The company also announced that it has received Scientific Advice from the European Medicines Agency (EMA) on the program, and has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the Phase III international randomized trial.
- This announcement is based on the outcome of the START trial. The START trial did not meet the primary endpoint of improving overall survival (OS) in the overall patient population. Data from an exploratory analysis of a predefined subgroup of patients in the START trial, who received tecemotide after concurrent chemoradiotherapy (CRT), showed that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo (n=806; HR: 0.78; 95% CI 0.64–0.95; p=0.016). Concurrent CRT is a combination of chemotherapy and radiotherapy given at the same time.
Is
general: Yes
