Phase II/III Trial of PD-1/VEGF Antibody in Small Cell Lung Cancer
Publication Title: 441TiP SEZanne: A phase II randomized, open-label, multicenter study to evaluate the optimal dose, safety, and efficacy of ABBV-706 in combination with atezolizumab (atezo) versus standard of care (SOC) in patients (pts) with previously untreated extensive-stage (ES) small cell lung cancer (SCLC)
Summary
- Question
- This study examines the effectiveness and safety of a new treatment approach combining PF-08634404, a bispecific antibody targeting PD-1 (a protein that suppresses the immune response) and VEGF (a protein promoting blood vessel growth in tumors), with chemotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC). The researchers aim to evaluate if this combination improves outcomes compared to the current standard treatment.
- Why it Matters
- Small cell lung cancer (SCLC) is an aggressive type of lung cancer with limited treatment options and a poor prognosis. Current therapies for extensive-stage SCLC provide only modest survival benefits, with most patients experiencing disease progression within months. This research is important because it explores a novel combination therapy that could potentially improve survival and treatment responses, addressing an urgent need for better therapeutic options in this patient population.
- Methods
- The study is divided into two phases: an initial Phase II trial to determine the optimal dose and assess safety, and a larger Phase III trial to evaluate effectiveness. Participants are adults with confirmed ES-SCLC who have not received prior systemic therapy. The Phase II portion involves 40 patients receiving PF-08634404 alongside chemotherapy drugs carboplatin and etoposide for four cycles, followed by PF-08634404 alone. The Phase III trial will enroll approximately 500 patients to compare the new combination therapy with the current standard of care, which includes chemotherapy and an anti-PD-L1 drug.
- Key Findings
- Preliminary findings from the Phase II trial suggest that PF-08634404, combined with chemotherapy, has a manageable safety profile and shows promising signs of effectiveness in treating ES-SCLC. Specific outcomes such as response rates, progression-free survival (the time patients live without the cancer worsening), and overall survival are being closely monitored to confirm these early results.
- Implications
- If successful, this treatment could represent a significant advancement in the care of ES-SCLC, offering improved survival and better disease control compared to existing therapies. The dual action of PF-08634404, targeting both immune suppression and tumor growth, provides a unique therapeutic approach that could also influence treatment strategies for other cancers.
- Next Steps
- The researchers plan to complete the ongoing Phase III trial to definitively evaluate the effectiveness and safety of PF-08634404 combined with chemotherapy. Future studies may also explore this combination therapy in other cancer types or investigate its long-term benefits and potential side effects.
- Funding Information
- This research was supported by Pfizer and AbbVie Inc., who provided funding for the respective clinical trials and medical writing support. The content is solely the responsibility of the authors and does not necessarily represent the official views of Pfizer or AbbVie Inc. Yale University also provided funding and support for this research.
Full Citation
Cuppens K, Goto Y, Byers L, Ardizzoni A, Paz-Ares L, Zhou C, Dowlati A, Cooper A, Bar J, Lee S, Jahchan N, Zhao Y, Meiman D, Fang F, Rivell G, Palenski T, Chiang A. 441TiP SEZanne: A phase II randomized, open-label, multicenter study to evaluate the optimal dose, safety, and efficacy of ABBV-706 in combination with atezolizumab (atezo) versus standard of care (SOC) in patients (pts) with previously untreated extensive-stage (ES) small cell lung cancer (SCLC). ESMO Open 2026, 11: 106755. DOI: 10.1016/j.esmoop.2026.106755.
Authors
K. Cuppens
First AuthorAnne Chiang, MD, PhD
Last AuthorAssociate Professor
Other Authors
Research Themes
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