The purpose of this Medical Access Program (also referred to as an Expanded AccessProgram in the USA) is to provide access to Dato-DXd for eligible patients withpreviously treated advanced or metastatic EGFR mutated non-small cell lung cancer (NSCLC)who, in their treating physician's opinion, have an unmet clinical need, are unlikely toobtain optimal benefit from currently approved and commercially available drugs, and whocannot enter a suitable clinical trial.
This is a Medical Access Program that will be available to adult patients with previously
treated advanced or metastatic EGFR mutated NSCLC who have no suitable treatment options
and are not able to enter a clinical trial.
Patients enrolled in the Medical Access Program can continue treatment until any of the
following occurs:
- Disease progression
- Unacceptable toxicity
- The benefit-risk no longer favors the individual
- Dato-DXd becomes commercially available and reimbursement is approved
- The patient chooses to discontinue treatment
- Withdrawal of consent
- Pregnancy
- Physician discretion
- Death
Patients enrolled in the Medical Access Program have an option to participate in
collection of safety-focused clinical practice data. This will contribute towards better
understanding of the clinical experience of treatment with Dato-DXd. Participation in
this optional data collection will have no bearing on receipt of treatment.
Drug: Datopotamab deruxtecan
6 mg/kg intravenous infusion Q3W (on Day 1 of each 21-day cycle)
Other Name: Dato-DXd,DS-1062a
Patients are only eligible after signing the informed consent form and must meet all of
the following criteria to be eligible for the Medical Access Program.
Inclusion Criteria:
- Patientsis aged ≥18 years (follow local regulatory requirements if the legal age of
consent for participation is >18 years old).
- The patient has histologically or cytologically documented advanced or metastatic
NSCLC that is not amenable to curative surgery or radiation.
- The patient must have documented AGAs in EGFR (for example, Ex19del, L858R, G719X,
S768I or L861Q, either alone or in combination with other EGFR mutations, which may
include T790M). Overexpression of EGFR in the absence of activating mutation is not
sufficient for enrollment.
- The patient must have progressed on at least 1 EGFR tyrosine kinase inhibitor and
platinum-based chemotherapy, either combined or in either sequence.
- The patient has adequate bone marrow reserve and organ function, based on local
laboratory data, in the opinion of the treating physician.
- If the patient is a female and of childbearing potential, a negative urine or serum
pregnancy test is required at time of treatment initiation request.
- If the patient (male and female) is of reproductive/childbearing potential, they
must agree to use a highly effective form of contraception or avoid intercourse
during the program and upon completion of this program and for at least 7 months for
females and 4 months for males after the last dose of Dato-DXd.
- Starting at the first dose of Dato-DXd, the patient agrees that if they are:
- A male patient, they must not freeze or donate sperm at any time during this
program and for at least 4 months after the last dose of Dato-DXd. Preservation
of sperm should be considered prior to the first dose of Dato-DXd.
- A female patient, they must not donate, or retrieve for their own use, ova at
any time during this program and for at least 7 months after the last dose of
Dato-DXd. Preservation of ova should be considered prior to the first dose of
Dato-DXd.
- The patient must have a life expectancy of >3 months as determined by the treating
physician.
- The patient is willing and able to provide written informed consent indicating that
they understand the purpose of the Medical Access Program and are willing and able
to participate.
Patients who meet any of the following criteria will not be eligible for the Medical
Access Program.
Exclusion Criteria:
- The patient has a history of non-infectious ILD/pneumonitis that required steroids,
has current ILD/pneumonitis, or have suspected ILD/pneumonitis that cannot be ruled
out by imaging at the time of entering the program.
- The patient has clinically severe respiratory compromise (based on treating
physician assessment) resulting from intercurrent pulmonary illnesses including, but
not limited to:
- Any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior
to program enrollment, severe asthma, severe chronic obstructive pulmonary
disease, moderate to severe restrictive lung disease, or moderate to severe
pleural effusion).
- Any autoimmune, connective tissue or inflammatory disorders with pulmonary
involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), OR
- Prior complete pneumonectomy.
- Patient has clinically significant unresolved toxicities from previous anticancer
therapy, defined as toxicities (other than alopecia) not yet resolved to National
Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
version 5.0, Grade >1 at start of treatment within the program. Patients with
chronic Grade 2 toxicities may be eligible at the discretion of the treating
physician after consultation with the Sponsor Medical Approvers or designees within
this program.
- Patient has active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus
(HCV) infection.
- Patient has active hepatitis C. (Active hepatitis C is defined by a positive Hep C
Ab result, quantitative HCV ribonucleic acid (RNA) results greater than the lower
limits of detection of the assay, and an ALT or AST greater than or equal to 2 times
the upper limit of normal.)
- Patient has uncontrolled hepatitis B. (Patients with hepatitis B [positive HBs
antigen test] must meet the following criteria to be eligible: have an HBV-DNA viral
load <2000 IU/mL off treatment or have an HBV-DNA viral load <2000 IU/mL on oral
antiviral therapy for at least 4 weeks and during the participation in the study.)
- The patient has known human immunodeficiency virus (HIV) infection that is not well
controlled. All of the following criteria are required to define an HIV infection
that is well controlled:
- Undetectable viral RNA.
- Cluster of differentiation 4 (CD4)+ count ≥350.
- No history of acquired immunodeficiency syndrome-defining opportunistic
infection within the past 12 months, and stable for at least 4 weeks on the
same anti-HIV medications (meaning there are no expected further changes in
that time to the number or type of antiretroviral drugs in the regimen).
- If an HIV infection meets the above criteria, monitoring of viral RNA load and
CD4+ count is recommended. Patients must be tested for HIV during the screening
period if acceptable by local regulations or an institutional review board
(IRB)/ethics committee (EC).
- The patient has a history of severe hypersensitivity reactions to either the drug or
inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd.
- The patient has a history of severe hypersensitivity reactions to other monoclonal
antibodies.
- Female patient who is pregnant, breast-feeding, or intending to become pregnant.
- The patient has 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 if prescribed Dato-DXd.
- The patient has clinically significant corneal disease.
- The patient is currently participating in or is in active follow-up (as defined by
the protocol) for any Daiichi Sankyo or Astra Zeneca clinical study.
- The patient is eligible for any available oncology clinical trial.
- The patient has received a prior DNA topoisomerase 1 inhibitor (including as a
payload of an ADC).
- The patient has received prior radiotherapy to the brain within 2 weeks of start of
Dato-DXd treatment or received radiotherapy to the chest within 4 weeks of start of
Dato-DXd treatment, or the patient has ongoing radiation-related toxicities
requiring corticosteroids.
UC Irvine Health
Orange, California, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
Detroit, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
Central Care Cancer Center
Bolivar, Missouri, United States
Overlook Medical Center Medical Diagnostic Associates Atlantic Medical Group
Summit, New Jersey, United States
New York Cancer & Blood Specialists
New York, New York, United States
Houston Methodist Hospital Cancer Center
Houston, Texas, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Contact for Program Information
908-992-6400
patient.access@bionicalemas.com
Global Medical Affairs, Study Director
Daiichi Sankyo