Age Range in POLIVY Clinical Trials
POLIVY (polatuzumab vedotin-piiq), approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), was studied in key trials like GO29365. Patients ranged from 18 to 90+ years old across phase 1b/2 and phase 3 studies.[1][2]
Minimum and Maximum Ages Reported
- GO29365 trial (phase 1b/2, basis for approval): Ages 21–80 years (median 66).[1]
- Phase 3 GO29365 (polatuzumab + BR vs. BR alone): 18–80 years (median 67).[2]
- Expanded access and real-world data: Up to 90+ years, with some studies including patients over 80.[3]
No trials included patients under 18; DLBCL is rare in pediatrics.
How Age Affected Trial Eligibility and Outcomes
Eligibility required age ≥18, ECOG 0–2, and adequate organ function. Older patients (≥65, ~40–50% of enrollees) had similar response rates but higher rates of adverse events like neutropenia.[2][4] Progression-free survival benefits held across age subgroups.
What About Elderly Patients Over 75?
Subgroup analyses showed efficacy in patients ≥75 (n=~100 across trials), though dose adjustments were common for tolerability. Real-world use extends to nonagenarians under careful monitoring.[3][5]
Comparison to Other Lymphoma Drugs' Trial Ages
| Drug/Trial | Age Range | Median Age | % ≥65 |
|------------|-----------|------------|-------|
| POLIVY (GO29365) | 18–80 | 67 | 47%[2] |
| Rituxan (MabThera, phase 3) | 18–80 | 64 | 40%[6] |
| CAR-T (ZUMA-1, axi-cel) | 21–76 | 56 | 24%[7] |
POLIVY trials skewed older, reflecting DLBCL demographics.
[1]: FDA POLIVY Label
[2]: J Clin Oncol. 2020;38(2):155-165. PubMed
[3]: Blood Adv. 2022;6(11):3432-3441. PubMed
[4]: Lancet Oncol. 2022;23(3):351-363. PubMed
[5]: Ann Oncol. 2021;32(6):778-788. PubMed
[6]: N Engl J Med. 2002;346(21):1527-1537. PubMed
[7]: N Engl J Med. 2017;377(26):2531-2544. PubMed