Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT04248829 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. | Gefitnib 250 mg | 9.7 Months |
| Lazertinib 240 mg | 20.6 Months | |||
| NCT04487080 MARIPOSA | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) From randomization to either disease progression or death whichever occurs first (up to 32.8 months) | Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib | 16.59 Months |
| Experimental: Arm A (Open-label): Amivantamab + Lazertinib | 23.72 Months | |||
| Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib | 18.46 Months | |||
| NCT04988295 MARIPOSA-2 | Carcinoma, Non-Small-Cell Lung | Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months) | Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L) | 8.31 months |
| Main Study: Arm B: Carboplatin + Pemetrexed (CP) | 4.17 months | |||
| Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP) | 6.28 months | |||
| NCT05388669 PALOMA-3 | Carcinoma, Non-Small-Cell Lung | Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2 Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1 | Arm A: Lazertinib With Amivantamab SC-CF | 135861 micrograms*hour per milliliters (±30.7 Geometric Coefficient of Variation) |
| Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion | 131704 micrograms*hour per milliliters (±24.0 Geometric Coefficient of Variation) | |||
| NCT05388669 PALOMA-3 | Carcinoma, Non-Small-Cell Lung | For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State Pre-dose on Cycle 4 Day 1 (each cycle of 28 days) | Arm A: Lazertinib With Amivantamab SC-CF | 206 micrograms per milliliters (mcg/mL) (±39.1 Geometric Coefficient of Variation) |
| Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion | 144 micrograms per milliliters (mcg/mL) (±41.5 Geometric Coefficient of Variation) | |||
| NCT05388669 PALOMA-3 | Carcinoma, Non-Small-Cell Lung | For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab Pre-dose on Cycle 2 Day 1 (each cycle of 28 days) | Arm A: Lazertinib With Amivantamab SC-CF | 335 mcg/mL (±32.7 Geometric Coefficient of Variation) |
| Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion | 293 mcg/mL (±31.7 Geometric Coefficient of Variation) |