Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — Investor Presentation (August 2023)
11 slides from Puma Biotechnology's investor presentation, Aug 3, 2023
Slide 1: Clinical Development Strategy in Small-Cell Lung Cancer
Puma Biotechnology Clinical Development Strategy in Small-Cell Lung Cancer August 3, 2023 1
Slide 2: Phase 2 Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts Study design: • Pts had to have undergone ≤ 2 previous cytotoxic regimens, not including adjuvant or neoadjuvant treatments • Alisertib administration: orally in 21-day cycles at 50 mg twice daily for 7 days followed by a break of
Slide 3: Phase 2 Study of Alisertib Monotherapy: Tumor Response
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts 10 (21%; 95% CI 10–35) of 48 patients had an objective response; all responders achieved a partial response Change in target lesion size and best response (investigator assessed response) PD=progressive disease. SD=stable disease.
Slide 4: Alisertib Monotherapy: All-Cause Adverse Events in SCLC Cohort
Phase 2 Study of Alisertib Monotherapy in Solid Tumors - SCLC Cohorts All-cause adverse events in safety evaluable SCLC cohort (n=60) Table adapted from Melichar B Lancet Oncol 2015. Data are number of patients with AE (%) for AEs of any grade in at least 10% of patients overall. NA = not applicable
Slide 5: Randomized Phase 2 Paclitaxel plus Alisertib vs Placebo: Primary Analysis
Randomized Phase 2 Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Primary Analysis Study design: • Patients with relapsed or refractory SCLC stratified by relapse type (sensitive vs resistant or refractory) • Randomized 1:1 to alisertib + paclitaxel or placebo + p
Slide 6: Randomized Phase 2: Correlative Biomarker Analysis (c-Myc)
Randomized Phase 2 Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Correlative Biomarker Analysis Improved PFS observed among patients positive versus negative for c-Myc expression PFS in patients positive for c-Myc expression Median PFS 4.64 mo w/ paclitaxel + ali
Slide 7: Randomized Phase 2: Biomarker Analysis, Cell Cycle Gene Alterations
Randomized Phase 2 Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Correlative Biomarker Analysis Improved outcomes among pts with genetic alternations in cell cycle genes CDK6, RBL1, RBL2, and RB1 (collectively referred to as “mutant”) Owonikoko J Thorac Oncol 202
Slide 8: Randomized Phase 2 Paclitaxel plus Alisertib: Safety
Randomized Phase 2 Study of Paclitaxel plus Alisertib vs Paclitaxel plus Placebo as Second-Line SCLC: Safety AE, adverse event Owonikoko J Thorac Oncol 2020 8
Slide 9: PUMA-ALI-4201 study design
PUMA-ALI-4201 study design Key inclusion criteria • Pathologically confirmed ES-SCLC • Progression on or after first-line platinum- based chemo; must have prior immunotherapy Alisertib • Measurable disease per RECIST v1.1 N = up to 60 50 mg po BID on days 1-7 of every 21-day • Must provide tissue bi
Slide 10: Efficacy and safety objectives and endpoints
Efficacy and safety objectives and endpoints Objective Primary Endpoint • Proportion of patients with confirmed complete responses (CR) or partial responses (PR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Secondary Endpoints • Duration of response (DOR) • Di
Slide 11: Parallel Clinical and Biomarker Development
Parallel Clinical and Biomarker Development Comprehensive biomarker strategy supports clinical development and commercialization Drug Enrollment of ALI-4201 Data Amended ALI-4201 for biomarker Treatment development (up to 60 pts) Analysis defined population to support potential Accelerated Approval
Puma Biotechnology — Investor Presentation (August 2023) on 6ix