Slide 1: Interim 5-Year Analysis of iDFS Data from Phase III ExteNET Trial
Interim 5-Year Analysis of iDFS Data from Phase III ExteNET Trial July 2016 Copyright 2016 Puma Biotechnology
Slide 2: Forward-Looking Safe Harbor Statement
Forward-Looking Safe Harbor Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential indications of our drug candidates and the development of our drug
Slide 3: ExteNET: study design
ExteNET: study design HER2+ breast cancer (local) – IHC 3+ or ISH amplification Prior adjuvant trastuzumab & chemotherapy Lymph node ±, or residual invasive disease after neoadjuvant therapy ER/PR± Part APart BPart C Neratinib x 1 year iDFSiDFS 240 mg/day forfor upup RANDOMIZATION N=2840 --survival
Slide 4: Primary analysis: iDFS in ITT population
Primary analysis: iDFS in ITT population Intention-to-treat (ITT) population 100 97.8% 93.9% 90 95.6%2.3% 91.6% (%) 80 survival 70 free - Disease 60 50 NeratinibNeratinib TreatmentPlacebo 0 3691215182124 Months after randomization No. at risk Neratinib 1420 1291126012291189115011081033662 Placebo 14
Slide 5: HERA trial: landmark analysis
HERA trial: landmark analysis ITTHR+ HERA at 5 years follow-up equates with ExteNET at 4 years 100 100 89.1%90.3% 81.6%83.1% 80 86.7%75.8%8089.6%76.1% 81.0%82.9% 76.0%77.2% (%) (%) 60 60 survival survival free Patients Events HR (2 vs. 1)95% CIP valuefreePatients Events HR (2 vs. 1)95% CIP value - 4
Slide 6: 3-year (descriptive) analysis: iDFS in ITT population
3-year (descriptive) analysis: iDFS in ITT population (n=2840) Intention-to-treat population 100 97.8% 94.1%92.0% 90.5% 90 95.6%91.6%89.9%88.6% (%) 80 survival 70 free lue = 0.023 - 60 74 (0.56–0.96) Disease 50 NeratinibNeratinib TreatmentPlacebo 0 612182430364248 Months after randomization No. at r
Slide 7: 5-year interim iDFS analysis (ITT population: n=2840)
5-year interim iDFS analysis (ITT population: n=2840) Two-sided P-value = 0.017 HR (95% CI)=0.74 (0.58, 0.95) * p-value descriptive Copyright 2016 Puma Biotechnology
Slide 8: 3-year (descriptive) analysis: iDFS in centrally confirmed HER2+
3-year (descriptive) analysis: iDFS in centrally confirmed HER2+ Centrally confirmed HER2+ 100 97.7% 94.1%91.8% 90 94.8%90.4% 91.0%89.6%87.9% (%) 80 survival 70 free 70 lue (0.50–0.98) = 0.037 - 60 Disease 50 NeratinibNeratinib TreatmentPlacebo 0 612182430364248 Months after randomization No. at ris
Slide 9: 5-year interim iDFS analysis: Centrally-confirmed HER2+
5-year interim iDFS analysis: Centrally-confirmed HER2+ Two-sided P-value = 0.026 HR (95% CI)=0.70 (0.51, 0.96) * p-value descriptive Copyright 2016 Puma Biotechnology 9
Slide 10: 3-year (descriptive) analysis: iDFS by hormone receptor status
3-year (descriptive) analysis: iDFS by hormone receptor status HR + 100 98.0% 95.4%93.6% 92.3% 90 96.1% 91.5%89.3%87.9% (%) 80 survival 70 free lue = 0.003 - Disease 60 57 (0.39–0.82) Neratinib 50 Neratinib TreatmentPlacebo 0 612182430364248 Months after randomization No. at risk Neratinib 816 746 7
Slide 11: 5-year interim iDFS analysis: HR+
5-year interim iDFS analysis: HR+ Two-sided P-value = 0.002 HR (95% CI)=0.59 (0.41, 0.82) * p-value descriptive Copyright 2016 Puma Biotechnology 11
Slide 12: 5-year interim iDFS analysis: HR–
5-year interim iDFS analysis: HR– Two-sided P-value = 0.979 HR (95% CI)=1.00 (0.69, 1.44) * p-value descriptive Copyright 2016 Puma Biotechnology
Slide 13: Updated Data and 5-Year Interim Update
Updated Data and 5-Year Interim Update Included in both MAA and NDA submissions Included as Addendums Full 5-year DFS data anticipated in 2017 Copyright 2016 Puma Biotechnology