Safety
The overall safety profile
of POLIVY-R-CHP is similar to that
of R-CHOP and consistent with the
known risk of the individual study drugs1
Watch Expert Perspectives
Specialist views covering a range of POLARIX trial topics
Dr Hervé Tilly,
University of Rouen, France
Prof. Christopher Flowers,
MD, Anderson Cancer Center, University of Texas
Dr Franck Morschhauser,
MD, PhD Professor of Hematology,
University of Lille
Dr Laurie H. Sehn,
MD, MPH Clinical Assistant
Professor with the BC Cancer Agency and University
of British Columbia
Drug deliverability was similar in both treatment arms1
POLIVY-R-CHP VS R-CHOP
POLIVY-R-CHP VS
R-CHOP
More patients received all planned doses of polatuzumab vedotin in the POLIVY-R-CHP arm vs vincristine in the R-CHOP arm1
91.7%
88.5%
Fewer patients received a dose reduction due to adverse events in the POLIVY-R-CHP arm1
9.2%
13.0%
Overall safety profile1
| In 'number of patients' (%) |
||||
POLIVY-R-CHP (N=435) VS |
R-CHOP (N=438) |
|||
| Any-grade AEs | 426 (97.9) | 431 (98.4) |
||
|---|---|---|---|---|
| Grade 3-4 AEs | 251 (57.7) | 252 (57.5) | ||
| SAEs | 148 (34.0) | 134 (30.6) | ||
| Grade 5 AEs | 13 (3.0) | 10 (2.3) | ||
| AEs leading to treatment discontinuation | ||||
| Any treatment | 27 (6.2) | 29 (6.6) | ||
| Polatuzumab vedotin/vincristine | 19 (4.4) | 22 (5.0) | ||
| AEs leading to dose reduction (any treatment) |
40 (9.2) | 57 (13.0) | ||
No filter results
Top 5 most common adverse events1,*
POLIVY-R-CHP (N=435) |
R-CHOP (N=438) |
|||
| Adverse Event* In ‘number of patients’ (%) |
Any Grade |
Grade 3 or 4‡ |
Any Grade |
Grade 3 or 4‡ |
|---|---|---|---|---|
| Peripheral neuropathy† | 230 (52.9) |
7 (1.6) | 236 (53.9) | 5 (1.1) |
| Nausea |
181 (41.6) |
5 (1.1) | 161 (36.8) | 2 (0.5) |
| Neutropenia | 134 (30.8) | 123 (28.3) | 143 (32.6) | 135 (30.8) |
| Diarrhoea | 134 (30.8) | 17 (3.9) | 88 (20.1) | 8 (1.8) |
| Anaemia |
125 (28.7) |
52 (12.0) |
114 (26.0) |
37 (8.4) |
No filter results
POLIVY-R-CHP had fewer cases of peripheral neuropathy leading to discontinuations (0.2% vs R-CHOP: 0.9%)1
Of patients who experienced any grade peripheral neuropathy, a lower percentage had Grade ≥2 or higher events with POLIVY-R-CHP compared with R-CHOP (POLIVY-R-CHP: 13.8% vs R-CHOP: 16.7%)1
Rates of febrile neutropenia were higher with POLIVY-R-CHP vs R-CHOP (14.3% vs 8.0%), but this did not translate into greater overall rates of infection: Grade 3 or 4 infections were comparable (15.2% vs 12.6%, respectively)1
*Top 5 most common adverse events, defined as AEs of any grade that occurred in at least 12% of the patients in either treatment group.
†Peripheral neuropathy includes the following preferred terms from the system organ class of peripheral neuropathy: peripheral neuropathy, peripheral sensory neuropathy, paresthesia, hypoesthesia, polyneuropathy, peripheral motor neuropathy, dysesthesia, neuralgia, peripheral sensorimotor neuropathy, hypotonia, hyporeflexia, neuromyopathy, ear paresthesia, peroneal nerve palsy, and skin burning sensation.
‡The percentage of grade 5 adverse events reported in POLIVY-R-CHP and R-CHOP, respectively: any grade 5 AE (3, 2.3), pneumonia (0.9,0.7) unexplained death (0.9,0.2), sepsis or septic shock (0.2,0.7), acute kidney injury (0.2,0), cardiac death (0.2,0), intestinal perforation (0.2,0), respiratory failure (0.2,0), multiple organ dysfunction syndrome (0,0.2), complete atrioventricular block (0,0.2), injury (0,0.2).1
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AE=adverse event; N=size of population; POLIVY-R-CHP=polatuzumab vedotin + rituximab, cyclophosphamide, doxorubicin, prednisone; R-CHOP=rituximab + cyclophosphamide, doxorubicin, vincristine, prednisone.
References:
- Tilly H, et al. N Engl J Med. 2022;386:351-63.