ESMO TAT Virtual Congress 2021: Safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer

SAFETY, TOLERABILITY AND PRELIMINARY EFFICACY OF POZIOTINIB WITH TWICE DAILY DOSING STRATEGY IN EGFR/HER2 EXON 20 MUTANT NON-SMALL CELL LUNG CANCER

A Sacher, X Le, R Cornelissen, E Shum, J Suga, M Socinski, J Molina, E Haura, J Clarke, G Bhat, F Lebel, M Garassino

Presented by:

Adrian Sacher, MD, MMSc, FRCPC

Department of Medical Oncology and Hematology Princess Margaret Cancer Center, Toronto, Canada

Poziotinib is an investigational drug not approved for marketing

DECLARATION OF INTERESTS

Adrian Sacher, MD

Research Support (Institutional): AstraZeneca, Amgen, Genentech, Merck, Lilly, Pfizer, Bayer, BMS, Spectrum, GSK, Iovance, CRISPR Therapeutics, RAIN Therapeutics

Advisory Board Member & Honoraria: Amgen, AstraZeneca, Merck, Genentech-Roche, Bayer, BMS, Pfizer, Tesaro, KisoJi

Steering Committee: Iovance, Galvanize Therapeutics

ZENITH20: A PHASE 2 MULTI-COHORT INTERNATIONAL TRIAL

•  Primary

  Objectives

  •  Objective Response Rate (ORR)

•  Secondary

  •  Disease Control Rate (DCR)

  •  Duration of Response (DOR)

  •  Safety & Tolerability

ORR based on Central independent imaging review

Cohort 3: Primary endpoint criteria: ORR 95% lower bound >20%Cohort 5: Dosing exploration

Cohort 5

Previously Treated or First-line NSCLC with EGFR or HER2 exon 20 insertions

(6mg, 8mg BID; 10mg, 12mg, 16mg QD)

ZENITH20 COHORT 3 EFFICACY

Treatment ongoing, n (%)

Age, median (range)

12 (15) 60 (32-81)Female / Male, n

Time of follow up in months, median (range)

44 / 35 9.2 (0.8 - 19.8)

Objective Response Rate, n (%) 95% CI

22 (27.8) 18.4 - 39.1

Disease Control Rate, n (%) 95% CI

68 (86.1) 76.5 - 92.8

Duration of response in months, median (range)

6.5 (1.1 - 16.1+)Progression-free-survival in months, median (range)

7.2 (0.8 - 19.8+)Efficacy data based on central review using RECIST 1.1

40

30

Best%ChangefromBaselineinSumofDiameter

20

10

0

-10

-20

-30

-40

-50

-60

-70

Best Overall Response -80Partial Response -90Stable Disease

Progressive Disease -100Not Evaluable

-110

Waterfall Plot - Best Change from Baseline in Tumor volume

• • 91% (72/79) had tumor reduction

• • Median % tumor reduction = 25.5%

Treatment Ongong