On November 8, 2024 HUYABIO International reported it will present the final analysis of data from a phase 2 study evaluating HBI-8000 in combination with nivolumab (anti-PD1 therapy), a novel combination for the treatment of advanced and metastatic melanoma (Press release, HUYA Bioscience, NOV 8, 2024, View Source [SID1234648041]).

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The results will be presented by Study Chair, Dr. Nikhil Khushalani, Senior Member and Vice Chair, Department of Cutaneous Oncology from Moffitt Cancer Center, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting on Saturday, November 9.

HBI-8000, an oral drug, when combined with nivolumab has shown encouraging efficacy signals in treating patients with advanced and metastatic melanoma. This innovative therapy has clinically meaningful advantages over traditional double immune checkpoint inhibitor combinations, offering patients an oral treatment in combination with nivolumab that has enhanced efficacy and reduced toxicities.

"The promising results from the HBI-8000 and nivolumab combination represent a significant advancement in treating advanced melanoma," said Dr. Mireille Gillings, President, CEO & Executive Chair at HUYABIO. "Coupling oral convenience with a reduction in immune-related toxicities will give clinicians new tools to improve patient outcomes. We are proud to contribute to this new era of immunotherapy that prioritizes both efficacy and patient well-being."

"We are pleased to share the final Phase 2 results of the HBI-8000 and nivolumab combination in patients with advanced melanoma at this year’s SITC (Free SITC Whitepaper) conference," said Dr Nikhil Khushalani. "The combination appears safe and effective in this Phase 2 study, which may show great promise in this patient population. HBI-8000 plus nivolumab could be an important addition to the armamentarium of oncologists treating this disease and is currently being investigated in a Phase 3 study."

Title: HBI-8000, a class I histone deacetylase (HDAC) inhibitor, in combination with nivolumab for treatment of anti-PD(L)1-naive advanced melanoma: final analysis of Study HBI-8000-302

Abstract Number: 620

Authors: Nikhil I. Khushalani1 (Presenter), Andrew Brohl1, Joseph Markowitz1, Heather Yeckes-Rodin2, Lori McCormick1, Charlie Liu3, Mireille Gillings3, Gloria Lee3, and Zeynep Eroglu1

1H. Lee Moffitt Cancer Center, Tampa FL, 2Hematology-Oncology Associates of the Treasure Coast, Port. St. Lucie, FL, 3HUYABIO International, San Diego, CA, USA

Oral Presentation Date and Time: Saturday, November 9th at 3:44 PM CST

Addressing the Unmet Need for Innovative Melanoma Therapies

The combination of HBI-8000 and nivolumab represents a significant advancement in melanoma treatment. As the first combination therapy that does not rely on dual immune checkpoint inhibitors, it presents a desirable option for community practices and specialty cancer centers, particularly in regions with limited technical support. This therapy can potentially expand combination therapy for melanoma containing nivolumab-backbone beyond established markets in the U.S. and EU, providing access to more patients worldwide.

About the HBI-8000 Phase 2 Trial

The trial was a Phase 1b/2 trial evaluating the combination of HBI 8000 with nivolumab (an anti-PD1 immune checkpoint inhibitor) in advanced melanoma, kidney cancer and non-small cell lung cancer. The recommended Phase 2 dose of HBI-8000 was determined to be 30mg orally twice weekly (BIW) combined with intravenous nivolumab administered at the manufacturer’s approved dosing schedule. Patients with metastatic melanoma not previously treated with anti-PD(L)-1 inhibitor, with measurable disease, ECOG performance status 0-1, and adequate hematologic and biochemical parameters were enrolled. Previously treated stable brain metastases not requiring steroids were permitted. Disease status was assessed by standard imaging using RECIST v1.1 every 8 weeks. Treatment was continued until disease progression, unacceptable toxicity or completion of 24 months of therapy.
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