Abstract 13P
Background
The phase II ALTER1202 trial demonstrated that patients who received anlotinib after failing at least two systemic chemotherapy regimens exhibited improved progression-free survival (PFS) and overall survival (OS) compared to the placebo group. In an effort to further enhance outcomes for small-cell lung cancer patients who have exhausted first-line platinum-based chemotherapy options, researchers are investigating the combination of anlotinib and penpulimab, a novel PD-1 inhibitor.
Methods
This open-label, single-arm, multi-center, phase II exploratory study enrolled patients with small-cell lung cancer who had previously undergone platinum-based chemotherapy. Patients received a combination therapy consisting of penpulimab (200mg every three weeks) and anlotinib (10mg daily), following a 2-week on and 1-week off schedule, until disease progression, unacceptable toxicity, or study discontinuation. The primary objective was to assess antitumor activity using the RECIST v1.1 criteria, focusing on the objective response rate (ORR). Secondary objectives included evaluating antitumor activity through the disease control rate (DCR), duration of response (DOR), PFS, OS, and assessing the safety and tolerability of this combination therapy.
Results
As of September 17, 2023, 38 patients were enrolled in the study and had received treatment. Of these 38 patients, 38 were evaluable using RECIST criteria, revealing an ORR of 26.30% (10 out of 38) and a DCR of 68.42% (26 out of 38). The median PFS was 4.36 months, with 6-month and 12-month PFS rates of 21.05% and 10.53%, respectively. The median DOR was 8.03 months, and the median OS was 15.71 months. Among the patients, 26 out of 38 (68.42%) experienced treatment-related adverse events, with 10 patients (26.32%) reporting grade 3 or higher adverse events. The most common adverse events related to anlotinib were hepatic injury, hematoxicity, and hypertension.
Conclusions
The combination of penpulimab and anlotinib showed promising clinical benefits and a favorable safety profile in small-cell lung cancer patients after platinum-based chemotherapy.
Clinical trial identification
NCT05001971.
Legal entity responsible for the study
Hunan Provincial Cancer Hospital.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
170P - Targeting myeloid cells in non-small cell lung cancer and hepatocellular carcinoma: a window-of-opportunity trial of nivolumab with BMS-813160 (CCR2/5i) or BMS-986253 (anti-IL8)
Presenter: Nicholas Venturini
Session: Poster Display
171P - Immune landscape and CLEVER-1 expression in hepatoblastoma
Presenter: Ville Väyrynen
Session: Poster Display
172P - PLCE1 stabilizes ENO1 to enhance glycolysis in esophageal squamous cell carcinoma (ESCC) and induces an immune-suppressive tumor microenvironment
Presenter: Ju Yang
Session: Poster Display
173P - Depleting resident peritoneal macrophages is an effective treatment for peritoneal metastasized colorectal cancer
Presenter: Job Saris
Session: Poster Display
174P - Targeting SPHK1 in macrophages suppresses liver metastasis of colorectal cancer and decouples anti-tumor immunity from immunotherapy toxicity
Presenter: Yizhi Zhan
Session: Poster Display
175P - MicroRNA-548c: An Immune-Activator microRNA at the Tumor Microenvironment and Immune Milieu of Breast Cancer
Presenter: Alyaa Dawoud
Session: Poster Display
176P - Multiplex-immunoflourescence spatial patterns to predict triple-negative breast cancer molecular subtypes in the IMMUcan study
Presenter: Andrea Joaquin Garcia
Session: Poster Display
177P - The Immune-microenvironment Confers Chemoresistance in Breast cancer through activation of VEGFR2/STAT3/BIRC5 signaling
Presenter: Bhawna Deswal
Session: Poster Display
178P - Dynamics of breast cancer T cell repertoire during neoadjuvant chemotherapy / immunotherapy.
Presenter: Charlotte Birchall
Session: Poster Display
179P - Integrating multiplex immunofluorescence with gene expression data in the IMMUcan HER2-positive breast cancer cohort
Presenter: Mattia Rediti
Session: Poster Display