Results from the primary analysis of the phase 3 TRANSFORM trial show superiority of lisocabtagene maraleucel (liso-cel) over autologous stem cell transplant (i.e., current standard of care in second-line R/R LBCL). Liso-cel is an autologous, CD-19 directed, 4-1BB CAR T-cell therapy administered in equal doses of CD8+ and CD4+ CAR+ T cells.

Previously reported results of an interim analysis performed at a median follow-up of 6.2 months indicated that liso-cel was more effective than SOC as 2L treatment in patients with primary refractory or early relapsed LBCL.

International investigators presented primary analysis at the 2022 ASH Annual Meeting held December 10-13 in New Orleans.

Researchers randomly assigned 184 patients (1:1) to either the liso-cel or the SOC arms. Patients must have LBCL that relapsed within 12 months or refractory to frontline therapy and be candidates for autologous stem cell transplant. In the Liso-cel arm, bridging therapy with R-ICE/R-DHAP or R-GDP was permitted. In SOC arm, patients who achieved CR or PR after 3 cycles of RICE/R-DHAP or R-GDP received autoSCT. Crossover to Liso-cel was allowed.

In total, 73% were refractory to first-line (1L) treatment and 12.5% had double hit DLBCL. At a median follow up of 17.5 months, the primary endpoint of median EFS was not reached in Liso-cel vs 2.4 months in SOC.

Secondary endpoints were also strongly in favor of Liso-cel: CR 74% vs 43% SOC, mPFS was not reached vs 6.2 months SOC.

While not statistically significant, median OS trended better in Liso-cel (NR versus 29.9 months respectively; HR, 0.724; P = 0.0987); 67% of SOC arm crossed over to Liso-cel. There were 28 patients in the Liso-cel arm and 38 patients in the SOC arm who died mainly from disease progression. No new safety signals were observed.

These results together with ZUMA7 data (Yescarta in second line DLBCL) strongly support the use of CART19 cellular therapy as second line in relapsed refractory DLBCL.

What are your thoughts of these data and of using liso-cel as 2L treatment in patients with primary refractory or early relapsed large B-cell lymphoma (LBCL)? In your opinion, which patients would benefit most from liso-cel? How are you going to choose liso-cel vs axi-cel vs tisa-cel as your product of choice?

Results from the primary analysis of the phase 3 TRANSFORM trial show superiority of lisocabtagene maraleucel (liso-cel) over autologous stem cell transplant (i.e., current standard of care in second-line R/R LBCL). Liso-cel is an autologous, CD-19 directed, 4-1BB CAR T-cell therapy administered in equal doses of CD8+ and CD4+ CAR+ T cells.

Previously reported results of an interim analysis performed at a median follow-up of 6.2 months indicated that liso-cel was more effective than SOC as 2L treatment in patients with primary refractory or early relapsed LBCL.

International investigators presented primary analysis at the 2022 ASH Annual Meeting held December 10-13 in New Orleans.

Researchers randomly assigned 184 patients (1:1) to either the liso-cel or the SOC arms. Patients must have LBCL that relapsed within 12 months or refractory to frontline therapy and be candidates for autologous stem cell transplant. In the Liso-cel arm, bridging therapy with R-ICE/R-DHAP or R-GDP was permitted. In SOC arm, patients who achieved CR or PR after 3 cycles of RICE/R-DHAP or R-GDP received autoSCT. Crossover to Liso-cel was allowed.

In total, 73% were refractory to first-line (1L) treatment and 12.5% had double hit DLBCL. At a median follow up of 17.5 months, the primary endpoint of median EFS was not reached in Liso-cel vs 2.4 months in SOC.

Secondary endpoints were also strongly in favor of Liso-cel: CR 74% vs 43% SOC, mPFS was not reached vs 6.2 months SOC.

While not statistically significant, median OS trended better in Liso-cel (NR versus 29.9 months respectively; HR, 0.724; P = 0.0987); 67% of SOC arm crossed over to Liso-cel. There were 28 patients in the Liso-cel arm and 38 patients in the SOC arm who died mainly from disease progression. No new safety signals were observed.

These results together with ZUMA7 data (Yescarta in second line DLBCL) strongly support the use of CART19 cellular therapy as second line in relapsed refractory DLBCL.

What are your thoughts of these data and of using liso-cel as 2L treatment in patients with primary refractory or early relapsed large B-cell lymphoma (LBCL)? In your opinion, which patients would benefit most from liso-cel? How are you going to choose liso-cel vs axi-cel vs tisa-cel as your product of choice?