Appendix C2

FDA-CRS Form 2.0

Cover Letter for Application

Clinical Trial Application for Pembrolizumab Plus Chemotherapy

April 17, 2022

Dr. Oscar Guitierrez, Jr., D.V.M, MPA, PCVPH

Director General
Food and Drug Administration
1781 Civic Drive, Filinvest City
Alabang, Muntinlupa City

Attention: Jesusa Joyce N. Cirunay

Center for Drug Regulation and Research

Re: Clinical Trial Application/Import License Application/ Extension/Notification

Full title of the trial: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab
Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate
Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally
Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
Investigational Product Name/Code: Pembrolizumab Plus, Protocol number: MK-3475-B49
Clinical Trial Approval No: NCT04895358 (for approved CT)

Dear Director,

As a member of the Contract Research Organization (CRO) of XYC Research Organization (Phils.), I would
like to apply for the clinical trial to your good office. This is a clinical trial regarding the Randomized,
Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo
Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive,
Human Epidermal Growth Factor Receptor 2-Negative(HR+/HER2-) Locally Recurrent Inoperable or
Metastatic Breast Cancer (KEYNOTE-B49) with Protocol number: MK-3475-B49 (CT Identifier No.
NCT04895358). The investigational product is Pembrolizumab which is a chemotherapeutic drug which has
the target to treat neoplasms of the breast especially recurring neoplasms or inoperable metastatic
neoplasms; its proposed formulation is 200 mg administered via IV infusion. This clinical trial is proposed
to be conducted from June 18, 2021, to October 21, 2027 or in 7 years’ time.

The objectives of the clinical trial is to evaluate the safety and efficacy of Pembrolizumab plus a choice of
chemotherapy which will be compared to a placebo plus the investigator's choice of chemotherapy
in the treatment of chemotherapy-candidate hormone receptor positive, human epidermal growth factor
receptor 2- negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer, as per the
summary of the said product. The manufacturer of the investigational product is Merck Sharp & Dohme
B.V., Netherlands (Phone: +31-235682200) while the importer of the IP is Merck Sharp & Dohme (I.A.)
LLC, Philippines.

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 If there are any questions or queries, kindly contact the undersigned, Mr. Ruel Vincent Asubar through this
email: rvasubar@gmail.com and/ or with this telephone number: 4543301.

Thank you for your time and we look forward to your immediate and positive response.

Sincerely yours,

Ruel Vincent E. Asubar

Contract Research Organization of XYC
Research Organization (Phils.),
Quezon city, Philippines
09295357559

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