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SPECTRUM PHARMACEUTICALS, INC.

(SPPI)
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ESMO Congress 2021: Efficacy and Safety of Poziotinib in Treatment-na´ve NSCLC Harboring HER2 exon 20 Mutations: A Multinational Phase 2 Study (ZENITH20-4)

09/18/2021 | 09:02am EDT

Efficacy and Safety of Poziotinib in Treatment-naïve NSCLC Harboring HER2 exon 20 Mutations: A Multinational Phase 2 Study (ZENITH20-4)

Robin Cornelissen, MD

Pulmonary Medicine, Erasmus MC

University Medical Center, Rotterdam, Netherlands

DECLARATION OF INTERESTS

Robin Cornelissen

Commercial

Relationship(s)

Interest

Speaker's fee

Roche, Pfizer, BMS

Advisory board

MSD, Roche, Spectrum

Robin Cornelissen

Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

Background

  • EGFR and HER2 exon 20 insertion mutations are rare subsets of accounting for approximately 10% each of all mutations and 2-4% each in NSCLC
  • There is no approved therapy for either treatment-naïve or previously treated NSCLC with HER2 exon 20 mutations
  • Currently utilized treatments include chemotherapy agents with or without checkpoint inhibitors and TKIs. None are specific to exon 20 mutations. Efficacy reported in literature is mostly from small uncontrolled studies and varies widely 1- 5
    • Response rates range 6.9 - 35%
    • Median PFS range 3 to 7 months
  • Poziotinib is an oral pan-HER TKI with activity in patients with EGFR or HER2 exon 20 mutated
    NSCLC6

1Zhou 2020; 2Yang 2021; 3Xu 2020; 4Auliac 2019; 5Yuan 2020; 6Cornelissen, WLCLC 2021

Robin Cornelissen, MD

Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

ZENITH20: Multi-cohort Global Clinical Trial

Completed

Cohort 1

Previously treated

NSCLC with EGFR exon

20 insertions

Cohort 2

Previously treated

NSCLC with HER2 exon

20 insertions

Cohort 3

First-line NSCLC with

EGFR exon 20

insertions

Objectives

  • Primary
    • Objective Response Rate (ORR)
  • Secondary
    • Disease Control Rate (DCR)
    • Duration of Response (DOR)
    • Safety & Tolerability

ORR based on Central independent imaging review

Cohort 4: Primary Endpoint Criteria: ORR 95% CI Lower Bound >20%

Treatment:

  • 16 mg QD in first 48 patients (complete)
  • 8 mg BID in subsequent patients (enrolling)

Enrolling

4

20

Cohort 5

Exploratory Previously

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

Cohort 6

EGFR Osimertinib

Failures

Cohort 7

Atypical EGFR or HER2

mutations

Preliminary safety and efficacy data from Cohort 4 QD dosing being presented here

ZENITH20 Cohort 4: Patient Characteristics

1L HER2 exon 20

QD Dosing

BID dosing

Disposition

N=48

N=23*

n (%)

n (%)

Ongoing

4 (8)

14 (61)

Discontinued

44 (92)

9 (39)

Death

5 (10)

1 (4)

Disease progression

30 (63)

3 (13)

Adverse events

1 (2)

3 (13)

Other

8 (17)

2 (9)

Age, median (range)

60.5 (34, 87)

59 (27, 88)

Female / Male, n

26/22

13/10

White /Asian / Others, n

36/7/5

19/3/1

Smoker / Non-Smoker, n

15/33

5/18

ECOG Status: 0 / 1

17/31

7/13

* BID patients enrolling with majority ongoing

Robin Cornelissen, MD

Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

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 18 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 September 2021 13:01:01 UTC.


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Financials (USD)
Sales 2021 1,53 M - -
Net income 2021 -174 M - -
Net Debt 2021 - - -
P/E ratio 2021 -1,76x
Yield 2021 -
Capitalization 313 M 313 M -
Capi. / Sales 2021 204x
Capi. / Sales 2022 7,98x
Nbr of Employees 176
Free-Float 98,5%
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Joseph W. Turgeon President, Chief Executive Officer & Director
Kurt A. Gustafson Chief Financial Officer & Executive Vice President
William L. Ashton Chairman
Francois Lebel Chief Medical Officer
Lyndah K. Dreiling Senior Vice President-Clinical Development
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