Updated Phase II data for Roche’s polatuzumab vedotin in relapsed / refractory (R/R) follicular lymphoma (FL) and diffuse large b-cell lymphoma (DLBCL) patients were presented by Laurie Sehn, MD, during the 2018 ASCO conference.

The agent is a first-in-class anti-CD79b antibody drug conjugate. While data for FL patients showed no significant difference with the addition of polatuzumab, data for DLBCL patients was highly encouraging – which bodes well for the ongoing Phase III trial in that indication (POLARIX, NCT03274492) which is due to reach its primary completion date in December 2019.

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Dr Sehn reported results from Phase II randomised cohorts of bendamustine and rituximab (BR) versus polatuzumab and BR (pola-BR), in a one-to-one fashion, in both R/R FL and R/R DLBCL patients. BR is a regimen that is commonly used in both first line and R/R settings of FL and DLBCL. A total of 80 FL patients were randomised, however, there was no efficacy difference between the pola-BR and BR cohorts.

A total of 80 DLBCL patients were also randomised, and the pola-BR cohort in these patients showed significantly higher response rates – demonstrating a PET CR of 40%, as compared to only 15% in the BR cohort. This resulted in significantly higher progression-free survival and median overall survival for pola-BR in DLBCL patients, of 6.7 months versus two months, and  11.8 months versus 4.7 months, respectively, compared to BR. PET CR rates and survival times were significantly improved in the pola-BR cohort, regardless of the number of lines of therapy previously received or patient’s refractory status. The combined FL and DLBCL pola-BR cohorts did demonstrate a higher rate of adverse events across the board, with neutropenia being the most common one, and a higher rate of serious adverse events.

The results in FL suggest that pola-BR is not a valid treatment option for those patients. However, the encouraging results in DLBCL patients highlight polatuzumab vedotin as a drug which has the potential to alter the R/R DLBCL standard of care.

In the first-line DLBCL setting, session discussant Alison Moskowitz, MD, noted that R-CHOP (rituximab in combination with chemotherapy) is the standard of care for most patients. She noted that the ongoing POLARIX study, which is evaluating polatuzumab with R-CHP, versus R-CHOP, in untreated DLBCL patients, will help answer the question of whether this agent could also alter first-line DLBCL therapy.

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Polatuzumab vedotin has received Breakthrough Therapy designation and priority medicines designation by the FDA and EMA for patients with R/R DLBCL. As discussed, the Phase III POLARIX trial is in untreated DLBCL patients, while the Phase II trial in FL and DLBCL was in R/R patients, and so polatuzumab vedotin has the potential to become approved across all lines of DLBCL therapy. The only other approved targeted therapy in first-line DLBCL is rituximab. Prior to patent expiry for Rituxan, Roche held dominance in the first-line setting. Given that rituximab biosimilars are now approved, an approval for polatuzumab vedotin would allow Roche to maintain some dominance in that setting, while an approval in the R/R setting would allow it to compete with Celgene’s Revlimid (lenalidomide).

The POLARIX trial read-out by December 2019 will clarify some of the remaining questions regarding polatuzumab vedotin in first-line DLBCL, but based on the Phase II results presented, it also has the potential to alter the R/R DLBCL standard of care.

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