Two doses of polatuzumab vedotin (PoV, anti-CD79b antibody-drug conjugate) in patients (pts) with relapsed/refractory (RR) follicular lymphoma (FL): Durable responses at lower dose level.
Bibliographic record
Abstract
8503 Background: Based on early evidence of cumulative toxicity of PoV at a dose of 2.4 mg/kg (Morschhauser ASH 2014 NCT01691898), a dose of 1.8 mg/kg was explored. We report updated results of the dose comparison. Methods: Pts with RR FL received PoV at 2.4 mg/kg or 1.8 mg/kg with R at 375mg/m2 q21d until progression or unacceptable toxicity. 5 pts from PhI (Palanca-Wessels ASH 2013) treated at the 2.4 mg/kg dose were included. Data at completion of PoV treatment were compared with data after 8 cycles. Results: 25 pts received PoV+R at 2.4 mg/kg, and 20 at 1.8 mg/kg. Median follow up was 14 mos for 2.4 mg/kg and 8 mos for 1.8 mg/kg. Baseline characteristics were balanced, except for age (median 68 yrs 2.4 mg/kg, 62 yrs 1.8 mg/kg) and tumor volume (SPD 1824 mm2 2.4 mg/kg, 2655 mm21.8 mg/kg). 40% (10/25, 2.4 mg/kg) and 50% (10/20, 1.8 mg/kg) of pts were refractory to their last treatment. Pts received a median of 10 cycles of PoV+R at 2.4 mg/kg vs. 9.5 at 1.8 mg/kg. Dose intensity through cycle 8 was 88% for 2.4 mg/kg and 99% for 1.8 mg/kg. Safety is shown in Table. An 84 yr old pt in the 2.4 mg/kg cohort died 2 months after cycle 12 due to pulmonary congestion. ORR was similar for both dose levels: 19/25 (76%) at 2.4 mg/kg, 15/20 (75%) at 1.8 mg/kg. CR: 11/25 (44%) at 2.4 mg/kg, 2/20 (10%) at 1.8 mg/kg. After 8 cycles, CR: 32% at 2.4 mg/kg and 10% at 1.8 mg/kg. Median PFS: 15 mo at 2.4 mg/kg, n.r. at 1.8 mg/kg. Conclusions: PoV+R in RR FL showed high ORR at both doses, with higher CR at 2.4 mg/kg. AEs and d/c rates were reduced at both doses if only the first 8 cycles are considered vs. those reported through study completion. The safety of PoV can be improved by shorter treatment and/or lower dose. Updated PFS will be presented. Clinical trial information: NCT01691898.Safety of PoV+R. PoV+R 1.8 mg/kg all cycles 2.4 mg/kg all cycles 1.8 mg/kg 8 cycles 2.4 mg/kg 8 cycles n (%) 20 25 20 25 Any AE G3-4 Neutropenia Febr neutropenia SAE Deaths AE leading to d/c G2-4 PN1 G3+ infection 10 (50) 7 (35) 2 (10) 6 (30) - 6 (30) 8 (40) 1 (5) 13 (52) 4 (16) 1 (4) 8 (32) 1 (4) 14 (56) 18 (72) 3(12) 10 (50) 7 (35) 2 (10) 6 (30) - 5 (25) 5 (25) 1 (5) 13 (52) 4 (16) 1 (4) 6 (24) - 7 (28) 10 (40) 2 (8) AE per CTCAE V4.03. AEs G3/4 ≥ 10% reported. 1MedDRA SMQ peripheral neuropathy.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".