Merck Receives FDA Fast Track Designation for Evofosfamide for Treatment of Patients Living With Advanced Pancreatic Cancer

PR60477

DARMSTADT, Germany, May 12/PRN=KYODO JBN/ --

    - NOT INTENDED FOR US AND UK BASED MEDIA -

    - Evofosfamide is an investigational compound currently in Phase III trials

    - Advanced pancreatic cancer is second indication to receive FDA fast track

      designation for evofosfamide

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

in healthcare, life science and performance materials, today announced that the

U.S. Food and Drug Administration (FDA) has granted Fast Track designation for

the development of evofosfamide (previously known as TH-302), administered in

combination with gemcitabine, for the treatment of previously untreated

patients with metastatic or locally advanced unresectable pancreatic cancer.

Evofosfamide is an investigational hypoxia-activated prodrug thought to be

activated under severe tumor hypoxic conditions, a feature of many solid

tumors. The compound, currently in Phase III trials, is being developed in

collaboration with Threshold Pharmaceuticals, Inc.

    Merck over the past years has bolstered its growth platforms in healthcare,

life science and performance materials to provide solutions in areas with high

demand for innovation. In its biopharmaceuticals business, the company has

strengthened its research and development activities and is increasingly

counting on partnerships to optimize relevance and efficiency.

    "Merck is focused on discovering and developing innovative new therapeutic

options for cancers that are particularly difficult to treat," said Luciano

Rossetti, Head of Global Research and Development of Merck's biopharmaceutical

business, Merck Serono. "Many patients with pancreatic cancer present with

advanced, inoperable tumors, and there are limited treatment options currently

available for them. The Fast Track designation for evofosfamide in pancreatic

cancer - the second indication for this compound to receive Fast Track

designation from the FDA, following the granting of the designation in soft

tissue sarcoma - will help to facilitate the timely development of this

high-priority program for Merck Serono."

    Threshold received the first Fast Track designation for the development of

evofosfamide in combination with doxorubicin for the treatment of advanced soft

tissue sarcoma in November 2014.

    "We are pleased that evofosfamide has been granted Fast Track status for

the treatment of patients living with pancreatic cancer," said Barry Selick,

Ph.D., Chief Executive Officer of Threshold Pharmaceuticals, Merck's

co-development partner. "Evofosfamide is currently being studied in patients

with pancreatic cancer in the MAESTRO Phase III study, and based on current

projections, we expect that the number of protocol-specified events for the

trial may be reached in the second half of 2015, with the results of the

primary efficacy analyses to be available shortly thereafter."

    The FDA established the Fast Track designation process to facilitate the

development and expedite the review of drugs intended to treat serious or

life-threatening conditions that demonstrate the potential to address unmet

medical needs.

    Pancreatic cancer is a relatively uncommon, but lethal cancer.[1] Ranked as

the 12th most common cancer worldwide, it is the 7th most common cause of

cancer-related death, accounting for 4% of deaths.[1] With 93-95% of patients

dying from their disease within 5 years, pancreatic cancer has a low survival

rate.[2],[3] There has been little improvement seen in the survival of patients

with this disease over the past 30 years[4] and there remain limited treatment

options for pancreatic cancer.[5] Surgery remains the only curative approach

for pancreatic cancer;[5] however, many patients (80-85%) present with

advanced, inoperable disease.[6] For this large group of patients ineligible

for surgery,

the aim of treatment is prolongation of survival and palliation of symptoms.[7]

    References

    1) Ferlay J, et al. Int J Cancer 2015;136(5):E359-86.

    2) National Cancer Institute. SEER Stat Fact Sheets: Pancreas. Available at:

       http://seer.cancer.gov/statfacts/html/pancreas.html Accessed: May 2015.

    3) EUROCARE-4 database on cancer survival in Europe. Long-term survival

       expectations of cancer patients in Europe in 2000-2002. Available at:

       http://www.eurocare.it/Results/tabid/79/Default.aspx Accessed: May 2015.

    4) Siegel R, et al. CA Cancer J Clin 2012;62(1):10-29.

    5) Malik NK, et al. J Gastrointest Oncol 2012;3(4):326-34.

    6) Loc WS, et al. World J Gastroenterol 2014;20(40):14717-25.

    7) Seufferlein T, et al. Ann Oncol 2012;23(Suppl 7):vii33-40.

    For more information on Merck Serono in oncology, please visit:

http://www.globalcancernews.com.

    About Evofosfamide

    Evofosfamide (previously known as TH-302) is an investigational

hypoxia-activated prodrug that is thought to be activated under severe tumor

hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels

(hypoxia) in solid tumors are due to insufficient blood vessel supply.

Similarly, the bone marrow of patients with hematological malignancies has also

been shown, in some cases, to be severely hypoxic.

    Evofosfamide is currently under evaluation in two Phase III trials: one in

combination with doxorubicin versus doxorubicin alone in patients with locally

advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial),

and the other in combination with gemcitabine versus gemcitabine and placebo in

patients with locally advanced unresectable or metastatic pancreatic cancer

(the MAESTRO trial). Both Phase III trials are being conducted under Special

Protocol Assessment (SPA) agreements with the FDA. The FDA and the European

Commission have granted evofosfamide Orphan Drug designation for the treatment

of STS and pancreatic cancer. The FDA has also granted Fast Track designation

for

evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being

investigated in a Phase II trial for the treatment of non-squamous non-small

cell lung cancer, and in earlier-stage clinical trials of other solid tumors

and hematological malignancies.

    Merck signed a global license and co-development agreement for evofosfamide

with

Threshold Pharmaceuticals, Inc. in February 2012, with an option for Threshold

to

co-commercialize in the U.S.

    Evofosfamide is currently under clinical investigation and has not been

approved for use in the U.S., Europe, Canada, or elsewhere. Evofosfamide has

not yet been proven to be either safe or effective and any claims of safety and

effectiveness can be made only after regulatory review of the data and approval

of the labeled claims.

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    Merck is a leading company for innovative, top-quality high-tech products in

healthcare, life science and performance materials. The company has six

businesses - Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck

Millipore and Performance Materials - and generated sales of around EUR 11.3

billion in 2014. Around 39,000 employees work for Merck in 66 countries to

improve the quality of life for patients, to further the success of 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 holds the global rights to the Merck name

and brand. The only exceptions are Canada and the United States, where the

company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

    SOURCE: Merck KGaA