辉瑞和GSK合作开展新颖组合疗法黑色素瘤I/II期试验

辉瑞（Pfizer）和葛兰素史克（GSK）11月21日宣布，双方已达成了一项协议，在晚期/转移性黑色素瘤（melanoma）患者中开展一项I/II期研究（Study 200344），探索GSK抗癌药trametinib（GSK 1120212）和辉瑞抗癌药palbociclib（PD-0332991）组合疗法的疗效和安全性。

Study 200344是一项剂量递增、开放标签研究，旨在确定trametinib+palbociclib用于黑色素瘤患者的推荐组合方案（recommended combination regimen，RCR）。该研究还将在BRAF V600野生型黑色素瘤患者（包括携带NRAS突变）中，评估该组合方案对肿瘤生物标志物的影响、安全性、抗肿瘤活性。

该项协议的财务条款尚未披露。

关于trametinib：

Trametinib是一种MEK1和MEK2可以抑制剂，已获FDA批准以商品名Mekinist上市，用于携带BRAF V600E或V600K突变的不能手术切除或转移性黑色素瘤患者的治疗，Mekinist不适用于既往接受过BRAF抑制剂疗法的患者的治疗。

关于palbociclib：

Palbociclib是一种实验性口服、选择性细胞周期蛋白依赖性激酶（CDK）4和6（即CKD4和CDK6）抑制剂。FDA于2013年4月授予palbociclib突破性疗法认定，用于乳腺癌的潜在治疗。目前，palbociclib尚未获任何监管批准。

英文原文：Pfizer And GSK To Initiate Study Of Novel Combination Therapy In Patients With Melanoma

Phase I/II Study combines GSK’s trametinib and Pfizer’s palbociclib

Thursday, November 21, 2013 - 8:00am EST

Pfizer Inc. announced today that it has entered into an agreement with GSK to explore the anti-cancer efficacy and the safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in a Phase I/II study (Study 200344) in patients with advanced/metastatic melanoma.

Study 200344 is a dose-escalation, open-label study designed to determine the recommended combination regimen (RCR) for trametinib plus palbociclib in patients with melanoma.  The study will also evaluate the effect of the combination on tumor biomarkers, safety and anti-cancer activity in patients with BRAFV600 wild type melanoma, including those with NRAS mutations.

“Pfizer Oncology is committed to maximizing the value of our portfolio for patients through the study of novel combinations.  This includes combining our own cancer medicines with each other, as well as with those of other companies where there is strong scientific rationale,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.  “Emerging data suggest the potential for trametinib and palbociclib to work together to treat melanoma.  We look forward to collaborating with GSK to explore this potential and evaluate the clinical activity of this combination in melanoma.”

The two companies will collaborate on the study, which GSK will conduct.  Financial terms of the agreement were not disclosed.

Trametinib, a reversible inhibitor of MEK1 and MEK2, is approved by the U.S. Food and Drug Administration (FDA) under the name Mekinist? for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test.  Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.   

Palbociclib is an investigational oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6.  In April 2013, palbociclib received Breakthrough Therapy designation by the FDA for the potential treatment of patients with breast cancer. Palbociclib is not approved for any indication in any markets.