U102 Study Flashcards
(31 cards)
what is the study Design of U102
phase 1, global, multicenter, open-label, 2 part evaluating HER3-DXd in patients with unresectable or metastatic EGFRm mNSCLC
what are the 2 parts/phases of U102
- dose Escalation
- dose Expansion
how many patients were in the Dose Escalation phase
36
what were the Dose Cohorts used in the dose escalation phase
- 3.2 (4 patients)
- 4.8 (15 patients)
- 5.6 (12 patients)
- 6.4 (5 patients)
what was the Objective of the Dose Escalation phase
assess the safety and tolerability as well as the Recommended Dose for Expansion (RDE) for part 2 of the trial
what were the Patient Cohorts for phase 2 dose expansion
- EGFRm andocarcinoma HER3 DXd: 5.6mg/kg
- NSCLC w/o EGFR-activating mutations w/ progression following an anti-PD-1 or anti PD-L1 antibody based regimen & targeted therapy for patients with genomic alterations: 5.6mg/kg
- 3a. EGFRm NSCLC: 5.6mg/kg or adjusted RDE
- 3b. EGFRm NSCLC: Cycle 1, Day 1: 3.2mg/kg, Cycle 2, Day 1: 4.8mg/kg, Cycle 3, Day 1: 6.4mg/kg
- EGFRm NSCLC: 5.6mg/kg
what was the Objective of the part 2 Dose Expansion
investigate the antitumor activity of HER3-DXd
what were the Key Inclusion Criteria of Part 1 Dose Escalation
- > 18
- Unresectable/ Metastatic EGFRm mNSCLC
- > 1 measurable lesion per RESIST (Response Evaluation in Solid Tumors)
- ECOG PS of 0-1
what was the Objective of Part 1 Dose Escalation
- dose limiting toxicities (DLTs)
- summary of AEs
what were the Key Inclusion Criteria of Part 2 Dose Expansion
- > 18
- Unresectable/ Metastatic NSCLC with or without EGFR activating mutations
- disease progression during or after systemic therapy for locally advanced or metastatic disease that included > 1 platinum based chemo
- > 1 measurable lesion per RESIST
- ECOG PS 0-1
what was the Primary
Objective of Part 2 Dose Expansion
ORR by BICR
what do the RESIST (Response Evaluation in Solid Tumors) Guidelines consist of
- Complete Response (CR): no tumor, disappearance of all lesions
- Partial Response (PR): at least a 30% reduction in tumor/ lesions
- Progressive Disease (PD): at least a 20% increase in the lesion
- Stable Disease (SD): no PR or PD that is measurable or sufficient
the Dose Escalation and Dose Expansion Cohort (?) were the focus of the trial
Expansion Cohort 1: EGFRm adenocarcinoma
what was the number of patients in the Dose Escalation and Cohort 1 Expansion
81
what were the most common TEAE, Treatment Emergent Adverse Events (AEs starting/ worsening from start of study to 47 after end of study) for the Dose Escalation and Expansion Cohort 1
- fatigue, 64%
- nausea, 60%
what % of patients had serious TEAEs (those starting/ worsening after 47 days)
40% (32/81 patients)
what % of patients discontinued the Dose Escalation/ Expansion Cohort 1
9% (7/81)
what % of ILD occurred in the dose escalation/ expansion cohort 1
6% (5/81)
T/F: there was a Grade 5 (death) ILD case reported
False: there were no ILD cases above Grade 3 reported
of the 5 patients who experienced ILD how many were related to Patritumab according to Adjudication
4
how is TEAE (treatment adverse events) defined in the study
those AEs(adverse events) that started or worsened from the start date of treatment to 47 days after the study end
how is SAE (serious adverse events) defined
those AEs that continued past the 47 days for TEAE
what were the most common TEAEs occurring >3%
- thromobocytopenia, 26%
- neutropenia, 15%
- fatigue, 10%
when was U102 granted Breakthrough Designation
December 2021
