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MERCK KGAA'S L-BLP25 TRIAL DID NOT MEET PRIMARY ENDPOINT (ENG)


(The following press release from Merck KGaA was received by e-mail. It was not confirmed by the sender.)

News Release

Your Contact Phyllis Carter +49 6151 72-7144

Merck: Detailed Results of Phase III Trial of L-BLP25 in Patients With Non-Small Cell Lung Cancer (START) to be Presented at ASCO

• Confirmed: Primary endpoint of significantly improving overall survival not met • Predefined subgroup of patients receiving initial concurrent chemoradiotherapy: median overall survival of 30.8 months observed in patients treated with L-BLP25 compared to 20.6 months in patients receiving placebo (HR 0.78, p=0.016) in post hoc analysis • Detailed results to be presented on Tuesday, June 4

Darmstadt, May 16, 2013 – Merck announced today detailed results from the randomized Phase III START* trial of its investigational MUC1 antigen-specific cancer immunotherapy L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). These results will be presented at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in Chicago. The primary endpoint of improving overall survival (OS) was not met. In a predefined subgroup of patients receiving initial concurrent chemoradiotherapy (CRT), a combination of chemotherapy and radiotherapy given at the same time, a median overall survival of 30.8 months versus 20.6 months was observed based on a post hoc analysis in patients treated with L-BLP25 versus placebo respectively (HR 0.78, 95% CI 0.64–0.95, p=0.016, n=806). The results of the START trial will be presented during the Oral Abstract Session “Lung Cancer – Non-Small Cell Local-Regional / Small Cell / Other Thoracic Cancers” from 09.45 am to 12.45 pm on Tuesday, June 4.

The complete news release can be downloaded at the following link: http://news.merck.de/N/0/D589CE5EF4A133A7C1257B6C0046F5EA/$File/Start_Asco_engli sch.pdf

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Merck KGaA ,Darmstadt, Germany External Communications E-mail: Media.Relations@merck.de Hotline: +49 (0) 6151/72-5000

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