Puma Biotechnology Inc · NASDAQ:PBYI

Puma Biotechnology — Corporate Update (November 2020)

12 slides from Puma Biotechnology's corporate update, November 2020

  1. Slide 1: SUMMIT (PUMA-NER-5201) Basket Trial: EGFR exon 18 lung cancer cohort update

    SUMMIT (PUMA-NER-5201) Basket Trial EGFR exon 18 lung cancer cohort update 1

  2. Slide 2: EGFR exon 18 mutations are rare in NSCLC adenocarcinomas

    EGFR exon 18 mutations are rare in NSCLC adenocarcinomas: represents only 5% of all EGFR mutations detected in lung cancer EGFR mutations associated with drug resistance EGFR mutations associated with drug sensitivity EGFREGFR Exonexon 18 mutations 2 S.V. Sharma et al (2007) Nature Rev. Cancer. 7:16

  3. Slide 3: EGFR exon 18 mutations are highly sensitive to neratinib in vitro

    EGFR exon 18 mutations are highly sensitive to neratinib (irreversible pan-HER TKIs) in vitro studies Comparative TKI affects in EGFR exon 18+ cells Western blot analyses of transfected HEK293 cells Neratinib Source: Kobayashi et al. Clin Cancer Res 2015;21:5305-5313. 3

  4. Slide 4: EGFR exon 18 mutations are highly sensitive to neratinib in NSCLC patients from POC trial

    EGFR exon 18 mutations are highly sensitive to neratinib in NSCLC patients from POC trial Phase 2 trial of neratinib in lung cancer 4 of 167 (2%) patients had EGFR exon 18 mutations (G719X) – One patient did not have measurable disease by central review All patients with G719 mutations (n=4) had cli

  5. Slide 5: SUMMIT study design for EGFR exon 18 mutant lung cancer cohort

    SUMMIT study design for EGFR exon 18 mutant lung cancer cohort Study Endpoints and Trial Design Features Open label single arm cohort Primary endpoint Neratinib monotherapy • Objective response rate at first post-baseline tumor (240 mg, oral daily) assessment (Week 8) (ORRWk8) Secondary endpoints Ma

  6. Slide 6: Baseline demographics and patient characteristics

    EGFR exon 18 mutant lung cancer cohort receiving neratinib monotherapy: Baseline demographics and patient characteristics Patient characteristics Safety/Efficacy evaluable patients (n=11) Median (range), years 67 (56-83) <65 years, n (%) 4 (36) ≥65 years, n (%) 7 (64) Gender, n (%) Female 5 (45) Mal

  7. Slide 7: Efficacy summary

    EGFR exon 18 mutant lung cancer cohort receiving neratinib monotherapy: Efficacy summary Efficacy evaluable patients TKI Pre-Treated Parameter (n=11) (n=10) Objective response (confirmed),a n 4 4 CR 0 0 PR 4 4 Objective response rate, % (95% CI) 36 (11–69) 40 (12–74) Best overall response, n 6 6 CR

  8. Slide 8: Treatment duration, best response and best change in tumor

    EGFR exon 18 mutant lung cancer cohort receiving neratinib monotherapy: Treatment duration, best response and best change in tumor 100 0902 (G719A) 0711 (G719X) 7902 (G719C; E709K) 50 0758 (G719X) 0712 (G719X; S768I) % Change in Tumor 1910 (G719C; S768I; T790M) 0 7904 (G719X; S768I) 1900 (G719A; E70

  9. Slide 9: Most common treatment emergent adverse events >10%

    EGFR exon 18 mutant lung cancer cohort receiving neratinib monotherapy: Most common treatment emergent adverse events >10% Safety evaluable patients (n=11) TEAE Any grade Grade ≥ 3 Diarrhea 5 (45.5) 0 Vomiting 4 (36.4) 0 Constipation 3 (27.3) 0 Nausea 3 (27.3) 0 Decreased appetite 3 (27.3) 1 (9.1) D

  10. Slide 10: Characteristics of treatment emergent diarrhea

    EGFR exon 18 mutant lung cancer cohort receiving neratinib monotherapy: Characteristics of treatment emergent diarrhea Lung EGFR (N) (N = 11) Incidence of diarrhea, n (%)a Any grade 5 (45.5) Grade 1 4 (36.4) Grade 2 1 (9.1) Grade 3 0 Action taken with neratinib, n (%) Leading to temporary hold 0 Lea

  11. Slide 11: Historical response rates of afatinib in NSCLC patients with EGFR exon 18 mutations (G719X)

    Historical response rates of afatinib in NSCLC patients with EGFR exon 18 mutations (G719X) TKI-naïve patients TKI-pre-treated patients 11 Yang et al. Journal of Thoracic Oncology (2020) 15(5): 803-815

  12. Slide 12: Milestones for neratinib in EGFR exon 18 mutant lung cancer cohort in SUMMIT study

    Milestones for neratinib in EGFR exon 18 mutant lung cancer cohort in SUMMIT study § The success criteria for the 1st stage and 2nd stage of the Simon’s 2-stage design has been met § Enrollment in the 2nd stage is continuing up to a total of 30 patients § Anticipate presentation of additional data f

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