LOS ANGELES, Calif. — September 17, 2026

Puma Biotechnology announced the initiation of ALISCA®-Lung2 (PUMA-ALI-4202; NCT07465757), a Phase II clinical trial evaluating alisertib in combination with paclitaxel for patients with advanced small cell lung cancer (SCLC). The sequential dose-escalation study is expected to enroll approximately 50 patients whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. The trial expands Puma’s clinical development strategy for alisertib in SCLC and complements the company’s ongoing ALISCA-Lung1 study evaluating alisertib monotherapy.

Alisertib-Paclitaxel Combination Targets Advanced SCLC

ALISCA-Lung2 is designed to evaluate the safety and tolerability of alisertib when administered with paclitaxel, with objective response rate, duration of response, disease control rate, progression-free survival and overall survival included as secondary endpoints. Puma will also assess clinical biomarkers to identify patient populations that may derive greater benefit from treatment. Alisertib is an oral, selective small-molecule inhibitor of aurora kinase A, a target associated with cell-cycle regulation and cancer cell proliferation. The biomarker component of the trial is intended to support evaluation of potential molecular characteristics associated with response to aurora kinase A inhibition.

Phase II Program Builds on Earlier Alisertib Research

The ALISCA-Lung2 study builds on previous clinical investigations of alisertib in small cell lung cancer, including combination studies with paclitaxel. Puma said earlier clinical findings provide a rationale for continued evaluation of the combination and for investigating potential biomarker-defined patient subsets. The company is conducting ALISCA-Lung2 in patients whose disease has progressed following standard platinum-based chemotherapy and immunotherapy, a population in which additional treatment options remain limited. Results from the study are expected to provide additional information on the clinical activity and tolerability of the alisertib-paclitaxel combination..

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Puma Expands Alisertib Development Across Cancer Types

ALISCA-Lung2 adds a second Phase II SCLC development program for alisertib, alongside the ALISCA-Lung1 trial evaluating alisertib monotherapy in extensive-stage SCLC. Puma also initiated ALISCA-Breast1 in 2024 to evaluate alisertib in combination with endocrine therapy in patients with HER2-negative, hormone receptor-positive metastatic breast cancer. Puma acquired exclusive development and commercialization rights to alisertib in 2022 and is initially focusing its development on SCLC and breast cancer. The company’s portfolio also includes NERLYNX® (neratinib), an FDA-approved therapy for HER2-positive breast cancer, providing Puma with both commercial and clinical-stage oncology programs.

Source:Puma Biotechnology, press release