Pfizer Initiates Phase I Clinical Trial of Potential First-in-Class Integrin β6-Targeted ADC SGN-B6A in China

Jun 13, 2024 18:19 CST Updated 18:19

Pfizer

Pharmaceutical R&D Developer

On June 12, according to the CDE Clinical Trial Registration and Information Disclosure Platform, Pfizer's ADC new drugSGN-B6A Initiates Phase I Clinical Trial in ChinaSGNB6A-003 Study, Targeting Advanced Solid Tumors(Registration No.:CTR20242077）。

Source: CDE Official Website

SGN-B6A (Sigvotatug vedotin/SV) is a potential FIC-targeting integrin β6 (Integrin beta-6, IB6) ADC new drug acquired by Pfizer through the acquisition of Seagen.

Source: ASCO2024 (Unless otherwise specified, the source is the same as below)

At the 2024 ASCO Conference, Pfizer announced updated data from the Phase I clinical study SGNB6A-001 (Registration Number: NCT04389632) of SV for NSCLC.

The study included 117 NSCLC patients who received dose escalation and dose expansion regimens, with a median of 3 prior treatment lines. Among them, 87.2% had received platinum-based chemotherapy, and 92.3% had received PD-(L)1 therapy. The results showed:The cORR for all NSCLC patients was 19%., mDOR was 11.3 months, mPFS 3.5 months, and mOS 11.2 months. Among them,Patients with non-squamous NSCLC who have not received paclitaxel treatment had a cORR of 31%., mDOR was 11.6 months; and there was better benefit in PFS and OS,mPFS and mOS were 6.4 months and 16.3 months, respectively.

In terms of safetyIn NSCLC patients: the incidence rates of TEAE, ≥ Grade 3 TEAE, SAE, and TEAE leading to discontinuation were 98.3%, 47.0%, 34.2%, and 12.0%, respectively. The most common ≥ Grade 3 TEAEs were dyspnea (9.4%), fatigue (6.8%), and neutropenia (6.0%). Additionally, there was one case of treatment-related death (pneumonia).

Currently, Pfizer has launched the global Phase III clinical trial of SGN-B6A.SGNB6A-002 Research(Registration Number:NCT06012435），Comparison of Docetaxel Second- and Third-Line Treatment for Non-Squamous NSCLC, with a target enrollment of 600 people, the first participant was successfully enrolled in February this year,Expected 2026/2027 readout data.However, the study's trial regions do not include China, and yesterday's registration launch...SGNB6A-003 is the first clinical study initiated in China.

Last year, Pfizer made a significant entry into the ADC field by acquiring Seagen for approximately $43 billion. According to materials from Pfizer’s Oncology R&D Day at the end of February this year, Pfizer holds a substantial share among the ADC new drugs that have already been approved and launched on the market. In addition, multiple ADC new drugs are in the clinical stage, while the company is also actively developing next-generation ADC technologies.

Source: Pfizer Official Website

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