Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — San Antonio Breast Cancer Symposium 2021
21 slides from Puma Biotechnology's conference presentation, December 2021
Slide 1: Neratinib + fulvestrant + trastuzumab for HR+, HER2-mutant metastatic breast cancer: SUMMIT updates
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Neratinib + fulvestrant + trastuzumab for hormone-receptor positive, HER2-mutant metastatic breast cancer, and neratinib + trastuzumab for HER2-mutant metastatic triple-negative disease: latest updates from the SUMMIT trial Komal Jhaveri,1 Ha
Slide 2: Disclosures
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Disclosures The presenting author, Komal Jhaveri, has the following relevant financial relationship: – Research grant (institution): Puma Biotechnology Inc. This presentation is the intellectual This presentation property property is the inte
Slide 3: ERBB2 (HER2) mutations and neratinib
San Antonio Breast Cancer Symposium®, December 7-10, 2021 ERBB2 (HER2) mutations and neratinib HER2 mutations • HER2 mutations in the absence of gene amplification or protein overexpression are a unique mechanism of oncogenic addiction to HER2 signaling:1–3 – HER2 mutations are relatively rare, occu
Slide 4: Characteristics of HER2-mutant breast cancer
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Characteristics of HER2-mutant breast cancer1–8 Incidence Histology Genomics 2% Primary breast cancers Predominantly in hormone Occur across multiple domains receptor-positive (luminal-A) of the protein (KD, ECD, TMD) 2–4% MBC and HER2-negati
Slide 5: Initial SUMMIT multi-histology basket study design
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Initial SUMMIT multi-histology ‘basket’ study design: Neratinib monotherapy cohorts Key inclusion criteria Primary endpoint Bladder • Objective response rate at first (8 weeks) • Documented HER2 mutation Breast HR+ and HR– post-baseline tumor
Slide 6: Evolution of breast cancer cohorts in SUMMIT
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Evolution of breast cancer cohorts in SUMMIT Rational combinations determined by genomic profiling of pre-treatment and progression biopsies (tissue and ctDNA) HR+/HER2– Neratinib Neratinib + Fulvestrant2 monotherapy1 ORR: 30% (17–48) Neratin
Slide 7: Current SUMMIT breast cancer cohorts
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Current SUMMIT breast cancer cohorts • Added inclusion criteria for HR+ cohort to reflect current standard of care: prior CDK4/6 inhibitor therapy HER2-mutant MBC MBC cohort Treatment assignment HR+/HER2-negative MBC Neratinib + Fulvestrant (
Slide 8: HR+ patients: Key baseline characteristics & prior therapies
San Antonio Breast Cancer Symposium®, December 7-10, 2021 HR+ patientsa: Key baseline characteristics & prior therapies Randomized cohort Non-randomized All N+F+T Characteristics (N+F+T, n=26) (N+F+T, n=7) (F+T, n=7) (F, n=7) (N+F+T, n=33) ECOG performance status, n (%) 0 13 (50.0) 3 (42.9) 4 (57.1)
Slide 9: HR+ non-randomized N+F+T: Efficacy findings
San Antonio Breast Cancer Symposium®, December 7-10, 2021 HR+ non-randomized N+F+T: Efficacy findings Non-randomized Characteristics (N+F+T, n=26) Objective response (confirmed CR/PR)a, n (%) 12 (46.2) CR 0 PR 12 (46.2) Best overall response 15 (57.7) (confirmed or unconfirmed PR or CR), n (%) Media
Slide 10: HR+ randomized cohorts: Efficacy findings
San Antonio Breast Cancer Symposium®, December 7-10, 2021 HR+ randomized cohorts: Efficacy findings Neratinib appears to be critical for inhibition of HER2 mutations Randomized cohort Characteristics (N+F+T, n=7) (F+T, n=7) (F, n=7) Objective response (confirmed CR/PR)a, n (%) 2 (28.6) 0 0 CR 1 (14.
Slide 11: HR+ all N+F+T combined: Efficacy findings
San Antonio Breast Cancer Symposium®, December 7-10, 2021 HR+ all N+F+T combined: Efficacy findings Neratinib appears to be critical for inhibition of HER2 mutations All N+F+T N+F (subset, prior CDK4/6i) Characteristics (n=33) (n=14) Objective response (confirmed CR/PR)a, n (%) 14 (42.4) 4 (28.6) CR
Slide 12: HR+ patients: Response and duration of treatment
San Antonio Breast Cancer Symposium®, December 7-10, 2021 HR+ patients: Response and duration of treatment • Patients receiving N+F+T had greater decreases in tumor size and longer treatment duration than patients not treated with neratinib 140 N+F+T (randomized) 140 F+T (randomized) 120 120 Change
Slide 13: HR+ all N+F+T combined: Safety
San Antonio Breast Cancer Symposium®, December 7-10, 2021 HR+ all N+F+T combined: Safety All N+F+T (n=33) Most common treatment-emergent adverse eventsa, n (%) Any grade Grade 3/4 Diarrhea 30 (90.9) 15 (45.5)* Nausea 27 (81.8) 0 Vomiting 16 (48.5) 3 (9.1) Fatigue 16 (48.5) 3 (9.1) Constipation 13 (3
Slide 14: TNBC cohort: baseline characteristics and efficacy
San Antonio Breast Cancer Symposium®, December 7-10, 2021 TNBC cohort: baseline characteristics and efficacy TNBC TNBC Baseline characteristics (N+T, n=18) Efficacy (N+T, n=18) ECOG performance status, n (%) Objective response (confirmed CR/PR)a, n (%) 6 (33.3) 0 9 (50.0) CR 1 (5.6) 1 9 (50.0) PR 5
Slide 15: TNBC cohort: safety
San Antonio Breast Cancer Symposium®, December 7-10, 2021 TNBC cohort: safety TNBC (N+T, n=18) Most common TEAEs, n (%) Any grade Grade 3/4 Diarrhea 16 (88.9) 3 (16.7)* Nausea 9 (50.0) 1 (5.6) Vomiting 9 (50.0) 1 (5.6) Constipation 7 (38.9) 0 Fatigue 5 (27.8) 3 (16.7) Decreased appetite 4 (22.2) 0 A
Slide 16: Change in tumor size (target lesion) and characteristics
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Change in tumor size (target lesion) and characteristics Non-randomized Randomized Randomized Randomized HR+ HR+ HR+ HR+ Prior CDK4/6i Prior CDK4/6i Prior CDK4/6i Prior CDK4/6i TNBC N+F+T N+F+T F+T F N+T Best overall response CR PR SD 100 HER
Slide 17: Change in tumor size (target lesion) and characteristics
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Change in tumor size (target lesion) and characteristics Non-randomized Randomized Randomized Randomized HR+ HR+ HR+ HR+ Prior CDK4/6i Prior CDK4/6i Prior CDK4/6i Prior CDK4/6i TNBC N+F+T N+F+T F+T F N+T Best overall response CR PR SD 100 HER
Slide 18: Distribution of HER2 mutations and best response
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Distribution of HER2 mutations and best response • HER2 mutations were distributed throughout the kinase, transmembrane, and extracellular domains • Responses were reported in patients with HER2 mutations in any of these domains, in all nerat
Slide 19: Conclusions
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Conclusions The combination of N+F+T demonstrated encouraging clinical activity in patients with heavily pretreated HR+, HER2-negative, HER2-mutant MBC who had previously received CDK4/6i: – Objective response rate 42.4% (1 CR and 13 PRs); me
Slide 20: Next steps
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Next steps Following closure of the F+T and F arms of the randomized cohort, additional patients with HR+, HER2-negative, HER2-mutant MBC and prior CDK4/6i have been enrolled, totaling n=50 who have received N+F+T: – Safety and efficacy outco
Slide 21: Acknowledgements
San Antonio Breast Cancer Symposium®, December 7-10, 2021 Acknowledgements The authors would like to thank all patients and their families for participating in SUMMIT SUMMIT was sponsored by Puma Biotechnology Inc Puma Biotechnology Inc. funded the editorial/creative assistance for this presentation
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