GSK and Hansoh’s ADC clinches late-stage win, teeing up regulatory submission in China

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GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates.

GSK and Hansoh Pharmaceutical’s pivotal trial evaluating an experimental B7-H3-targeted antibody-drug conjugate (ADC) has hit the study’s main goal, extending overall survival for patients with small cell lung cancer.

The Phase 3 ARTEMIS-008 trial centers around risvutatug rezetecan (ris-rez), an ADC also known as HS-20093. GSK paid $185 million in December 2023 to secure exclusive global rights to ris-rez outside of China, Hong Kong, Macau and Taiwan in a deal that could max out at $1.7 billion.

Hansoh’s trial, which took place in China, met its primary endpoint of overall survival when compared to the standard of care for advanced SCLC, according to a July 10 GSK release, though the pharma did not share data specifics behind the win.

The findings represent the first positive Phase 3 overall survival data for a B7-H3-targeted ADC in any tumor type, according to GSK.

With an upfront payment of $185 million, GSK on Wednesday added another exclusive antibody-drug conjugate license agreement with China-based Hansoh Pharma.

The open-label study enrolled about 460 patients, randomizing participants to receive either ris-rez or chemotherapy. Besides demonstrating a statistically significant survival improvement, the ADC showed “consistent benefit” across key secondary endpoints, including progression-free survival, according to GSK. No new safety signals were recorded, aligning with prior ris-rez safety findings, the U.K. pharma said.

Hansoh plans on using the data to underpin a regulatory submission in China. Meanwhile, GSK intends to keep advancing the ADC across multiple tumor types, including in an open-label Phase 3 SCLC study that launched last year. The global pivotal trial is expected to readout by the end of next year.

GSK is one of numerous pharmas that have turned to China biotechs to develop cancer candidates. In recent days, Pfizer made a $650 million cash payment to access Innovent Biologics’ antibody therapy pipeline in a deal that could top $9.8 billion, while Bristol Myers Squibb teamed up with Hengrui Pharma to develop 13 oncology or immune assets in a pact worth more than $15 billion in biobucks.

As for Hansoh, the Jiangsu-based company has flourished in the deal-making scene, touting separate obesity partnerships with both Regeneron and Merck, an ADC pact with Roche and a collaboration with London RNA biotech Silence Therapeutics, among others. In April, new biotech Tortugas Neuroscience emerged with an undisclosed neuropsychiatric asset licensed from Hansoh.

GSK
Gabrielle is a senior editor at BioSpace. You can reach her at gabrielle.masson@biospace.com.
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