TABLE 4.
Comparison between time to first response (TTFR), time to disease progression (TTP), and median PFS in Phase 3 clinical trials.
| Trial registration number | Treatment arm(s) | Timing of scans | Number of patients (TTFR) | TTFR per LI (months, 95% CI) | TTFR per BICR (months, 95% CI) | Number of patients | Time to progression (TTP) per LI (months, 95% CI) | Time to progression (TTP) per BICR (months, 95% CI) | Median PFS per LI (months, 95% CI) | Median PFS per BICR (months, 95% CI) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5 | NCT00689936 | Arm 1: lenalidomide + low-dose DEX (until disease progression) | After each treatment cycle and every 28 days during the follow-up phase | Arm 1: 402 | Arm 1: 1.8 (0.50–22.2) | Arm 1: 1.8 (0.7–22.2) | Arm 1: 535 | NA | NA | Arm 1: 26.0 (20.7–29.7) | Arm 1: 25.5 (20.7–29.4) |
| Arm 2: lenalidomide + low-dose DEX (18 cycles) | Arm 2: 397 | Arm 2: 1.8 (0.8–34.8) | Arm 2: 1.8 (0.8–17.1) | Arm 2: 541 | Arm 2: 21.0 (19.7–22.4) | Arm 2: 20.7 (19.4–22.0) | |||||
| Arm 3/AC: melphalan + prednisone + thalidomide | Arm 3/AC: 341 | Arm 3/AC: 2.8 (1.2–56.3) | Arm 3/AC: 2.8 (1.3–49.7) | Arm 3/AC: 547 | Arm 3/AC: 21.9 (19.8–23.9) | Arm 3/AC: 21.2 (19.3–23.2) | |||||
| 13 | NCT03052608 | E: lorlatinib | Every 8 weeks (±1 week) | E: 113 | NA | E: 1.8 (1.7–1.9) | E: 149 | NA | NA | E: NR (NR to NR) | E: NR (NR to NR) |
| AC: crizotinib | AC: 85 | AC: 1.8 (1.7–1.9) | AC: 147 | AC: 9.1 (7.4–10.9) | AC: 9.3 (7.6–11.1) | ||||||
| 17 | NCT02603432 | E (Arm A): avelumab plus best supportive care (BSC) | Every 8 weeks for 12 months and then every 12 weeks | LI | E (Arm A): 2.0 (1.8–22.2) | E (Arm A): 2.0 (1.7–16.4) | E (Arm A): 350 | NA | NA | E (Arm A): 5.5 (4.2–7.2) | E (Arm A): 3.7 (3.5–5.5) |
| Arm B: best supportive care (BSC) alone | E (Arm A): 43 | Arm B: 1.9 (1.1–10.9) | Arm B: 2.0 (1.8–7.0) | Arm B: 350 | Arm B: 2.1 (1.9–3.0) | Arm B: 2.0 (1.9–2.7) | |||||
| Arm B: 12 | |||||||||||
| BICR | |||||||||||
| E (Arm A): 34 | |||||||||||
| Arm B: 5 |
Trials that were included in our initial analysis (Dello Russo et al., 2021) are highlighted in gray. ITT, intention to treat population; ORR, objective response rate; PFS, progression-free survival; BICR, blind independent central review; NA, not available; NR, not reached.