Amgen
Blincyto plus chemotherapy demonstrated significant overall survival versus SoC in adults with Ph-negative B-ALL, who were measurable residual disease-negative following induction and intense chemotherapy.
Amgen presented the data of the Phase 3 E1910 trial, demonstrating the efficacy of Blincyto plus chemotherapy versus standard of care.
The drug is under evaluation in adults with Philadelphia chromosome-negative B-ALL who were measurable residual disease (MRD)-negative and previously treated with induction and intense chemotherapy.
After a median follow-up of 43 months, there was a significant improvement in the overall survival in the Blincyto arm; median OS was not achieved in the Blincyto arm versus 71.4 months in patients on the control arm. 83% of patients were alive after 3.5 years in patients on Blinyto plus chemotherapy versus 65% on chemotherapy only.
The safety profile was consistent with the existing safety profile.
Gilead
Gilead presented the data from the ZUMA-7 trial, supporting the use of Yescarta in earlier lines of treatment in patients with r/rLBCL
Gilead presented the two new analyses from the ZUMA-7 trial, demonstrating the efficacy of Yescarta (axicabtagene ciloleucel) as an earlier or second-line treatment in patients with relapsed or refractory large B-cell lymphoma.
Gilead has presented the ZUMA-7 trial to support the US Food and Drug Administration's approval to use Yescarta in earlier lines of treatment.
In the ZUMA-7 trial, when Yescarta was administered as second-line therapy, only 47% of patients required subsequent therapies compared to 71% of patients requiring subsequent treatment who received standard of care as second-line therapy. In patients who received chemotherapy as third-line treatment following Yescarta's treatment, the median progression-free survival was 1.7 months, the median overall survival was 8.1 months, and the objective response rate was 25%. In the patients who received immunotherapy following Yescarta's treatment as a third-line treatment, the median progression-free survival was 3.5 months.
Further, Gilead also presented the data of metabolic tumor volume (MTV) and clinical outcomes, event-free survival (EFS), demonstrating the better efficacy of Yescarta versus standard of care. The progression-free survival was superior in low and high MTV patients versus the standard of care.
Yescarta has a boxed warning in the US FDA label and can cause CRS and neurological toxicities.
AbbVie
Navitoclax and ruxolitinib reduced bone marrow fibrosis and variant allele frequency.
AbbVie announced the Phase 2 REFINE study, demonstrating the efficacy of navitoclax and ruxolitinib in myelofibrosis naive patients.
The Spleen Volume Reduction (SVR) of greater than or equal to 35% from baseline was the primary endpoint; there was an improvement in SVR35 at week 24 in higher-risk groups.
In fifty percent of patients, there was a reduction in driver gene mutation VAF > 20% from baseline at week 24, and 18% of patients achieved >50% VAF from baseline.
78% of patients reported one or more adverse events. Thrombocytopenia was observed in 47% of patients, anemia in 34% of patients, and neutropenia in 25% of patients.
Roche
Polivy updated data demonstrated a significant reduction in the risk of disease worsening or death in DLBCL patients.
Roche presented the Phase III POLARIX study of Polivy (polatuzumab vedotin), an anti-CD79b antibody-drug conjugate, demonstrating the efficacy in patients with untreated diffuse large B-cell lymphoma (DLBCL).
Polivy plus rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) showed similar health-related quality-of-life outcomes while demonstrating superior progression-free survival.
After a median follow-up of 39.7 months, Polivy plus R-CHP showed a significant reduction in risk of disease worsening or death versus Rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
There was an improvement in fatigue and physical functioning in the Polivy arm versus R-CHOP; 74.8% versus 68.2% improved fatigue, and 42.4% versus 39.6% showed improvement in physical functioning.
More than fifty countries have approved Polivy plus R-CHP combination in adults with untreated DLBCL. The supplemental BLA was accepted by the FDA in the US, and the decision is expected in April 2023.
Hemlibra demonstrated meaningful bleed control in infants with severe hemophilia A
Roche announced the Phase 3 HAVEN 7, demonstrating the efficacy in infants with hemophilia A.
Without factor VIII inhibitors, 77.8% of infants had no bleeds, and 42.6% of infants did not have treated or untreated bleeds.
There is a significant impact on the quality of life in infants with hemophilia A.
Its safety profile is consistent with the established safety profile; 16.7% of patients reported Hemlibra-related adverse events.
Crovalimab showed transfusion avoidance and hemolysis in PNH patients.
Roche presented the positive data of the phase III COMMODORE 3 study in China, demonstrating the efficacy in patients with paroxysmal nocturnal hemoglobinuria (PNH). COMMODORE 3 trial is the first China-specific study; there are limited therapies available in China.
Crovalimab, a novel anti-C5 recycling monoclonal antibody, has received Breakthrough Therapy Designation and Priority Review in China.
The COMMODORE 3 Phase 3 trial recruited 51 patients, the percent of patients with hemolysis control and the percentage of patients with transfusion avoidance were considered co-primary endpoints.
78.7% of participants had hemolysis control from week 5 to week 25. There is a significant difference in transfusion avoidance with crovalimab treatment.
GSK
GSK announced the phase III MOMENTUM trial demonstrating the durable response of momelotinib in patients with myelofibrosis
GSK announced that, at 48 weeks, momelotinib maintained total symptom response and transfusion independence in patients who responded in the first 24 weeks. Further, transfusion independence was associated with overall survival.
At week 48, 97% of patients showed TSS response at week 24 and maintained until week 48, 90% of patients showed TI response at week 24 maintained until week 48, and 100% of patients had SRR response at week 24 maintained until week 48.
In the primary analysis, momelotinib met the primary endpoint of TSS reduction of ≥50% over 28 days before the end of week 24 compared to baseline.
Novartis
Iptacopan demonstrated an increase in hemoglobin levels in complement inhibitor naive patients.
Novartis presented the Phase 3 APPOINT-PNH study, demonstrating the efficacy of iptacopan in patients who are complement-inhibitor naive.
In the APPOINT-PNH trial, the primary endpoint is, in the absence of blood transfusion, the proportion of patients achieving a sustained increase in hemoglobin levels of ≥ 2 g/dL. Iptacopan was administered 200 mg twice daily in the APPOINT-PNH study. Iptacopan met the primary endpoint.
PNH is an indication of high unmet need; despite different C5 inhibitors available, patients remain anemic and fatigued and depend on blood transfusions.
Johnson and Johnson
Janssen presented the early study results of Tecvayli, Darzalex Faspro, and lenalidomide combination in relapsed or refractory multiple myeloma.
Janssen presented the Phase 1b MajesTEC-2 new results, evaluating the combination of Tecvayli (teclistamab), Darzalex Faspro (daratumumab and hyaluronidase), and lenalidomide combination in patients with relapsed or refractory multiple myeloma who were previously treated with one to three lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
After a median follow-up of 8.4 months, the overall response rate (ORR) was 93.5%; 54.8% of patients achieved complete response. 80.6% of patients have remained progression-free at the time of data cut-off.
The most common adverse events reported are neutropenia, thrombocytopenia, and cytokine release syndrome.
Janssen aims to strengthen its multiple myeloma portfolio with first-in-class GPRC5DxCD3 bispecific antibody talquetamab
Jansen presented the updated results of the MonumenTAL-1 trial, a Phase 1/2 trial evaluating the efficacy of talquetamab in heavily pretreated multiple myeloma patients.
Talquetamab targets the multiple myeloma cells (by acting on GPRC5D) and increases the body's immune response against cancer (by targeting CD3 on T cells). Talquetamab was evaluated in patients previously treated with a median of five prior lines of therapy.
After a median duration of 14.9 months, in patients administered with 0.4mg/kg talquetamab subcutaneously, the overall response rate was 74.1%, 59.4% of patients achieved a very good partial response (VGPR), 33.6% of patients achieved complete response, and 23.8% of patient achieved stringent complete response. The median progression-free survival was 7.5 months.
After a median follow-up of 8.6 months, in patients administered with 0.8mg/kg of talquetamab subcutaneously, the overall response rate was 73.1%, 57.2% of patients achieved a very good partial response (VGPR), 32.4% of patients achieved complete response, and 20% of patient achieved stringent complete response.
The common adverse events are cytokine release syndrome, skin-related AEs, and nail-related AEs.
Pfizer
Pfizer presented the follow-up data of B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody, elranatamab, in patients with multiple myeloma.
Pfizer presented 10.4 months follow-up data of elranatamab, a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) in patients with advanced multiple myeloma. Elranatamab is under evaluation in the pivotal Phase 2 MagnetisMM-3 trial, in which 123 patients were recruited.
Elranatamab is under assessment in heavily pretreated patients who received three classes of prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
During the maintenance period, elranatamab 76 mg was administered on a 28-day cycle; 12 and 32 mg were used for step-up priming during cycle 1. After a median follow-up of 10.4 months, 61% of patients achieved a high objective response rate, with 84% showing a probability of maintaining response at nine months.
Pfizer announced that the safety profile is manageable, and cytokine release syndrome and neurotoxicity syndrome were observed in the trial.