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Bristol-Myers Squibb’s  regimen receives approval from Singapore’s Health Sciences Authority in unresectable skin cancer

19 June 2017 | News

This is the first HSA-approved combination of immune checkpoint inhibitors.

Singapore – Bristol-Myers Squibb Pte Ltd, a global biopharmaceutical company announced that the Singapore Health Science Authority (HSA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with unresectable (unable to be removed by surgery) or metastatic melanoma. This approval is based on data from the Phase 3 CheckMate -067 trial, in which theOpdivo + Yervoy Regimen demonstrated superior progression-free survival (PFS) and objective response rate (ORR).

Opdivo and Yervoy are immune checkpoint inhibitors that target separate, distinct and complementary checkpoint pathways (PD-1 and CTLA-4). Dual immune checkpoint inhibition targets cancer cells that may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system, shielding the tumour from immune attack. Yervoy stimulates cells that help fight the cancer while Opdivo allows these cells to recognize the cancer and attack it. The dual mechanism of action results in increased anti-tumour activity.

Every year in Singapore, there are 1,719 and 1,381 cases of skin cancer (including melanoma) in men and women respectively – this makes skin cancer among the top ten most common cancers in both males and females in Singapore.

“Patients with metastatic melanoma historically have a very challenging disease. It is one of the most aggressive and resistant cancers in humans. Treatment outcome with standard conventional chemotherapy is poor and prognosis is guarded,” said Adjunct Associate Professor Richard Quek, Senior Consultant and Deputy Head, Division of Medical Oncology, National Cancer Centre Singapore.

“Immunotherapy has undoubtedly revolutionized cancer care. The CheckMate-067 study is notable not only for improving progression-free survival and response rates in patients with advanced melanoma, but also as proof of concept that harnessing the power of immune system through separate pathways can be complementary,” said Dr. Zee Ying Kiat, Senior Consultant Medical Oncologist at Parkway Cancer Centre in Singapore. “The approval for combination nivolumab and ipilimumab represents another step forward in improving outcomes for patients with advanced melanoma.”

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