Merck Discontinues Clinical Development Program of Tecemotide as a Monotherapy in Stage III Non-Small Cell Lung Cancer

PR57865

DARMSTADT, Germany, Sep. 13, 2014 /PRN=KYODO JBN/ --

    - Not intended for UK-based media

    Merck announced today 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).

    Luciano Rossetti, Global Head of Research & Development at Merck Serono,

said: "While the data from the exploratory subgroup analysis in the START

trial[1] generated a reasonable hypothesis to warrant additional study, 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 as a monotherapy in NSCLC in order to refocus our

efforts on other promising candidates in our pipeline, like our anti-PD-L1

antibody MSB0010718C. Merck Serono remains committed to developing new

treatment options for patients with difficult-to-treat cancers."

    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 greater than or equal to50 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.

    Merck Serono continues to evaluate a number of investigational compounds

for difficult-to-treat cancers, and remains committed to improving the lives of

cancer patients and their families.

    References

    1) Butts C, et al. Lancet Oncol 2014;15(1):59-68.

    About tecemotide

    Tecemotide 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, including NSCLC, and has multiple roles in tumor growth and survival.

Tecemotide was being investigated in the Phase III START2, START and INSPIRE

trials for the treatment of unresectable, locally advanced Stage III NSCLC.

    Merck obtained the exclusive worldwide rights for development and

commercialization of tecemotide from Oncothyreon Inc., Seattle, Washington,

U.S., 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 tecemotide with Ono

Pharmaceutical Co., Ltd., Osaka, Japan.

    The START2 study is a Phase III, multicenter, 1:1 randomized, double-blind,

placebo-controlled 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 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, which began in

April 2014, expected to recruit about 1,000 patients. The study's primary

endpoint is OS. Secondary endpoints include time to symptom progression, PFS

and TTP.

    The basis for the START2 trial was the outcome of the initial START study.

START did not meet the primary endpoint of demonstrating an improved OS with

tecemotide compared with placebo in the overall patient population (n=1,239).

Median OS was 25.6 months for patients in the tecemotide group compared with

22.3 months for those in the placebo group (adjusted hazard ratio [HR]: 0.88;

95% confidence interval [CI]: 0.75-1.03; p=0.123). However, data from an

exploratory analysis of a pre-defined subgroup of patients in the START trial,

who received tecemotide after concurrent 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).

    INSPIRE is a Phase III, multicenter, randomized, double-blind,

placebo-controlled clinical trial 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 CRT. INSPIRE expected to

recruit approximately 500 Stage III NSCLC patients across China, Hong Kong,

Korea, Singapore and Taiwan.

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    Merck is a leading company for innovative and top-quality high-tech

products in the pharmaceutical and chemical sectors. With its four divisions

Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck

generated total revenues of EUR 11.1 billion in 2013. Around 39,000 Merck

employees work in 66 countries to improve the quality of life for patients, to

further the success of our customers and to help meet global challenges. Merck

is the world's oldest pharmaceutical and chemical company - since 1668, the

company has stood for innovation, business success and responsible

entrepreneurship. Holding an approximately 70% interest, the founding family

remains the majority owner of the company to this day. Merck, Darmstadt,

Germany is holding the global rights to the Merck name and brand. The only

exceptions are Canada and the United States, where the company is known as EMD.

    SOURCE: Merck KGaA