SPECTRUM PHARMACEUTICALS, INC.

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2021 ASCO Annual Meeting: CNS activity of poziotinib in NSCLC with exon 20 insertion mutations

06/04/2021 | 09:23am EDT

RD-POZ-0013

CNS ACTIVITY OF POZIOTINIB IN NSCLC WITH EXON 20 INSERTION MUTATIONS

Xiuning Le1, Marina C Garassino2, Robin Cornelissen3, Mark A Socinski4, Nishan Tchekmedyian5, Julian R Molina6, Christina S Baik7, Arsela Prelaj8, Chul Kim9, Sharon Leu10, Lyndah K Dreiling10, Francois Lebel10, Jeffrey M Clarke11

1The University of Texas MD Anderson Cancer Center, Houston, TX; 2University of Chicago Medical Center, Chicago, IL; 3Erasmus Medical Center, Rotterdam, Netherlands; 4AdventHealth Cancer Institute, Orlando, FL; 5Pacific Shores Medical Group, Huntington Beach, CA; 6Mayo Clinic, Rochester, MN; 7Seattle Cancer Care Alliance, Seattle, WA; 8Istituto Nazionale Tumori of Milan, Italy; 9 Georgetown University, Washington DC; 10Spectrum Pharmaceuticals, Irvine, CA; 11Duke University Medical Center, Durham, NC

Poziotinib is an investigational drug not approved by the FDA

Disclosures

Xiuning Le, receives consulting/advisory fees from EMD Serono (Merck KGaA), AstraZeneca, Spectrum Pharmaceuticals, Inc., Eli Lilly, Boehringer Ingelheim, Bristol-Myers Squibb and Celgene, and Research Funding from Eli Lilly, and Boehringer Ingelheim.

3

Introduction

  • Metastatic NSCLC harboring EGFR or HER2 exon 20 insertion mutations is a uniformly fatal disease and represents an unmet medical need
  • Brain metastasis in NSCLC is frequent, occurs in up to 25% of patients and is associated with short survival (mOS of 2-5 months following WBRT1)
  • Poziotinib is a potent, irreversible TKI that targets exon 20 insertion mutations
  • Two previous case reports in exon 20 mutated brain metastases suggest poziotinib CNS penetration2, 3
  • Here we present poziotinib CNS activity in NSCLC with EGFR or HER2 exon 20 insertion mutations in the ongoing ZENITH20 Study

1Langer CJ, Mehta MP. et al. J Clin Oncol. 2005 2Pandey A et al, Clin Breast Cancer, 2018

3Tchekmedyian N, et al. JTO Clin and Res Reports, 2020

Xiuning Le, MD PhD

The University of Texas MD Anderson Cancer Center

Figure 1. ZENITH20 Phase 2 Multi-cohort International Trial

Fully Enrolled

Cohort 1

Previously treated

NSCLC with EGFR exon

20 insertions (16mg QD)

Cohort 2

Previously treated

NSCLC with HER2 exon

20 insertions (16mg QD)

Cohort 3

First-line NSCLC with

EGFR exon 20

insertions (16mg QD)

Objectives

  • Primary
    • Objective Response Rate (ORR)
      • Based on Central Independent Review
  • Secondary
    • Duration of Response (DOR)
    • Safety & Tolerability
  • Baseline CNS assessment required only in

symptomatic patients

  • Stable CNS metastasis allowed if:
  • Asymptomatic, without requirement for high-dose steroids or anti-convulsant therapy
  • After recent RT, sequential post-txt MRI ≥ 4 wks showing stable disease
  • Intracranial assessment based modified RECIST by central review

Enrolling

Cohort 4

First-line NSCLC with

HER2 exon 20

insertions

(16mg QD; 8mg BID)

Cohort 5

NSCLC with EGFR or

HER2 exon 20 mut

(6mg, 8mg BID;

10mg, 12mg, 16mg QD)

Cohort 6

EGFR Osimertinib

Failures

(8mg BID)

Cohort 7

Atypical EGFR or HER2

mutations (8mg BID)

Table 1. Demographics and Patient Disposition

5

CNS Subgroup

Non-CNS Subgroup

All Patients

N=36

N=248

N=284

Median age, yrs (range)

58.5 (30, 75)

61 (25, 86)

60.5 (25, 86)

Gender: female / male

25 / 11

154 / 94

179 / 105

ECOG Status: 0 / 1

13 / 23

108 / 140

12 / 163

n (%)

EGFR

22 (61)

172 (69)

194 (68)

HER2

14 (39)

76 (31)

90 (32)

Length of Follow-up (months)

Median (Min, Max)

5.5 (0.9, 11.1)

9.2 (0.03, 26.0)

9.2 (0.03, 26.0)

Pooled analysis ZENITH20 cohorts 1-3

Xiuning Le, MD PhD

The University of Texas MD Anderson Cancer Center

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Spectrum Pharmaceuticals Inc. published this content on 04 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 June 2021 13:22:07 UTC.


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