Merck Serono has started dosing patients in an international Phase III START2 trial of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) to treat unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

The multicentre, 1:1 randomised, double-blind, placebo-controlled Phase III trial is designed to evaluate 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).

The current standard of care for most of NSCLC patients is concurrent CRT, which is a combination of chemotherapy and radiotherapy given at the same time.

A total of 1,000 patients are expected to be enrolled in the trial at about 250 sites in over 20 countries.

The trial’s primary endpoint is overall survival (OS), while secondary endpoints include time to symptom progression, progression-free survival and time to progression.

Merck received Scientific Advice from the European Medicines Agency (EMA) on the programme, and reached an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the trial.

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By GlobalData

The basis for the new Phase III trial is the outcome of the initial START trial, which failed to meet the primary endpoint of showing an improved OS with tecemotide compared with placebo in the overall patient population.

"The results of the initial START study provided scientific and clinical evidence to inform the design of this new pivotal Phase III programme."

However, data from an exploratory analysis of a pre-defined subgroup of patients in the START trial, who received tecemotide after concurrent CRT, demonstrated that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo.

Merck Serono global head of clinical development John Orloff said there is clearly a very real need for additional treatment options for people fighting NSCLC.

"The results of the initial START study provided scientific and clinical evidence to inform the design of this new pivotal Phase III programme," Orloff said.

"We are pleased that START2 is now underway, and feel confident that this study will address the appropriate gaps in understanding the potential role that tecemotide could play in the management of patients living with unresectable stage III NSCLC."

Tecemotide is designed to stimulate the body’s immune system to identify and target cancer cells expressing the cell-surface glycoprotein MUC1, which is expressed in many cancers, including NSCLC, and has multiple roles in tumour growth and survival.

Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.