Official Title
Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)
Brief Summary

The purpose of this Medical Access Program is to provide access to HER3-DXd for eligible patients with NSCLC who, in their treating physician's opinion, have an unmet clinical need which cannot be treated with approved and commercially available drugs and who cannot enter a clinical trial prior to commercial availability.

Detailed Description

This is a Medical Access Program which will be available to adult patients in the US with
metastatic or locally advanced EGFRm NSCLC who have received at least 2 prior systemic
therapies, who have no alternative commercially available treatment options, and are not able
to enter a clinical trial.

In this Medical Access Program, eligible patients will be treated with HER3-DXd and will
continue to receive treatment until any of the following occurs:

- Disease progression

- Unacceptable toxicity

- The benefit-risk no longer favors the individual

- HER3-DXd becomes commercially available in the US and reimbursement is approved for the
concerned indication of the Medical Access Program.

- Withdrawal of consent

- Pregnancy

- Physician discretion

- Death

Available
Treatment IND/Protocol
Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer

Drug: HER3-DXd

5.6 mg/kg Q3W [on Day 1 of each 21-day cycle]) infused IV over approximately 90 minutes
Other Name: U3-1402

Eligibility Criteria

Inclusion Criteria - Initial Requests

- Written informed consent

- Male or female aged ≥18 years (or local regulatory requirements)

- Histologically or cytologically documented locally advanced or metastatic EGFRm NSCLC
not amenable to curative surgery or radiation

- Documentation of radiological disease progression whilst on/after receiving most
recent treatment regimen for locally advanced or metastatic disease. Patients must
have received both of the following:

1. Prior treatment with any EGFR TKI, with at least one of them being osimertinib.
Patients receiving an EGFR TKI at the time of signing informed consent should
continue to take the EGFR TKI until 5 days prior to the first infusion of HER3
DXd.

2. Systemic therapy with at least 1 PBC regimen.

- Documentation of an EGFR-activating mutation detected from tumor tissue or blood (exon
19 deletion or L858R mutation).

- Eastern Cooperative Oncology Group performance status of 0 or 1 at the time of
entering the Medical Access Program.

- Adequate levels of bone marrow reserve and organ function

- 7. Female patients of childbearing potential must have a negative urine or serum
pregnancy test at the time of entering the Medical Access Program and must be willing
to use highly effective contraception during the treatment period and for at least 7
months following the last dose of HER3-DXd. Additionally, female patients must agree
to not donate, or retrieve for their own use, eggs from the time of entering the
Medical Access Program and throughout the treatment period, and for at least 7 months
after the final HER3-DXd administration. Male patients with female partners who are
able to become pregnant must be willing to use a highly effective form of
contraception or avoid intercourse during the treatment period and for at least 4
months following the last dose of HER3- DXd. Additionally, male patients must agree
not freeze or donate sperm from time of entering the Medical Access Program and
throughout the treatment period, and for at least 4 months after final dose of HER3-
DXd.

- Life expectancy of >3 months

Inclusion Criteria - Resupply Requests

- Treating physician must confirm that the patient is deriving continued benefit from
treatment.

- Treating physician must confirm that all required safety information has been reported
as per local laws/regulations,

Exclusion Criteria - Initial Requests

- Patient has participated in the HERTHENA-Lung02 'Trial of Patritumab Deruxtecan
Initiated in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer'
(NCT05338970) clinical trial.

- Patient has previous or current histologic or cytologic evidence of small cell OR
combined small cell/non-small cell disease in the archival tumor tissue or pre
treatment tumor biopsy.

- Patient has any history of ILD (including pulmonary fibrosis or radiation
pneumonitis), has current ILD, or is suspected to have such disease by imaging at the
time of entering the Medical Access Program.

- Patient has clinically severe respiratory compromise (based on treating physician's
assessment) resulting from intercurrent pulmonary illnesses including, but not limited
to: a) any underlying pulmonary disorder, b) any autoimmune, connective tissue or
inflammatory disorders, c) prior complete pneumonectomy

- Inadequate washout period prior to the first HER3-DXd infusion as specified in
protocol

- Clinically significant unresolved toxicities from previous anticancer therapy, defined
as toxicities (other than alopecia) not yet resolved to National Cancer Institute
Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) Grade ≤1 or baseline

- Active hepatitis B virus (HBV) and/or hepatitis C virus infection, such as those with
serologic evidence of viral infection within 28 days of the first HER3-DXd infusion

- Human immunodeficiency virus (HIV) infection that is not well controlled

- History of hypersensitivity to either the drug substance or any excipients in HER3-DXd

- Female patient who is pregnant, breast-feeding, or intending to become pregnant

- Prior or ongoing clinically relevant illness, medical condition, surgical history,
physical finding, or laboratory abnormality that, in the treating physician's opinion,
could affect the safety of the patient.

- Clinically significant corneal disease.

- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States

Investigator: Principal Investigator

Contacts

Contact for Program Information
9089926400
patient.access@bionicalemas.com

Program Team Lead, Study Director
Daiichi Sankyo

Daiichi Sankyo
NCT Number
Keywords
EGFR-mutated non small cell lung cancer
HER3 DXd
U3-1402
MeSH Terms
Carcinoma, Non-Small-Cell Lung
Patritumab deruxtecan