Pfizer Advances Sigvotatug Vedotin into Phase 3 Trial for Non-Squamous NSCLC Following Positive Phase 1 Results

May 24, 2024 07:50 CST Updated 07:50

Pfizer

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▎WuXiEdited by Kant Content Team

Today, the American Society of Clinical Oncology (ASCO) released abstracts for the majority of studies to be presented at the 2024 annual meeting. Among them, Pfizer'sAntibody-Drug Conjugate (ADC) Sigvotatug VedotinPositive results were obtained in the Phase 1 clinical trial for the treatment of non-small cell lung cancer (NSCLC). Based on this result,Pfizer has initiated a pivotal Phase 3 clinical trial to evaluate the efficacy of this ADC as a second- or third-line therapy for patients with non-squamous NSCLC.

Sigvotatug vedotin is an antibody-drug conjugate targeting integrin β6 (IB6)., initially developed by Seagen,Engineering modifications to the antibody enable sigvotatug vedotin to specifically target IB6 without binding to other integrins, thereby enhancing the tumor selectivity of this ADC.

▲Introduction to Sigvotatug Vedotin (Image Source:Pfizer, Inc. Official Website)

The updated results published in the ASCO annual meeting abstracts showed that the confirmed objective response rate (cORR) was 19.5% in the phase 1 clinical trial.In the subgroup of non-squamous NSCLC patients who had not received prior taxane treatment, the cORR reached 32.5%.Detailed patient characteristics and efficacy outcomes are shown in the figure below.

▲Sigvotatug vedotin Phase 1 Clinical Trial Update Results (Image Source:Reference [1])

In terms of safety, the proportion of treatment-emergent adverse events (TEAEs) greater than Grade 3 in NSCLC patients was 46.0%, and the proportion of TEAEs leading to discontinuation was 13.3%. The most common TEAEs greater than Grade 3 were dyspnea (9.7%), fatigue (7.1%), and neutropenia (5.3%). One NSCLC patient experienced treatment-related death (pneumonia).

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References:

[1] Efficacy and safety of sigvotatug vedotin, an investigational ADC, in NSCLC: Updated phase 1 results (SGNB6A-001). Retrieved May 23, 2024, from https://meetings.asco.org/abstracts-presentations/232886

[2] Pfizer shares the ADC data that convinced it to start a Phase 3 lung cancer trial. Retrieved May 23, 2024, from https://endpts.com/asco24-pfizer-shares-the-adc-data-that-convinced-it-to-start-a-phase-3-lung-cancer-trial/

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