Janssen Announces Positive Phase III GLOW Trial Results for Imbruvica Plus Venclexta in First-Line CLL/SLL

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On June 14, according to foreign media reports, Johnson & Johnson's Imbruvica in combination with Genentech's Venclexta (venetoclax), a Roche company, achieved success in a Phase III GLOW study evaluating the combination therapy as a first-line treatment for elderly or medically unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

This study, conducted by Janssen, a subsidiary of Johnson & Johnson, compared the Imbruvica + Venclexta combination therapy with chlorambucil + obinutuzumab (Clb+O) in this patient population. The data demonstrated that oral Imbruvica + Venclexta yielded superior progression-free survival (PFS) compared to other combination infusion regimens. Furthermore, the study showed that Imbruvica + Venclexta prolonged the duration of response and significantly improved the depth of response in the patient population. Data from this Phase III study were presented at the ongoing European Hematology Association (EHA) Congress.

Imbruvica and Venclexta have complementary mechanisms of action. Results from the GLOW study and the Phase II CAPTIVATE study demonstrate that this oral regimen provides an effective and flexible treatment option for patients with these disease types. Across these two studies, over 400 patients received the combination therapy, demonstrating the potential of Imbruvica across multiple patient cohorts.

Data from the GLOW study show that a fixed-duration, once-daily oral combination therapy of Imbruvica and venetoclax is superior to the standard chemoimmunotherapy regimen. This represents the first comparative evidence indicating that this regimen may improve patients' depth of response. At a median follow-up of 27.7 months, the Independent Review Committee found that the combination of Imbruvica and Venclexta provided progression-free survival outcomes superior to Clb+O. Johnson & Johnson stated that the improvement in progression-free survival was consistent across pre-defined subgroups, including older patients and those with higher comorbidity scores.

In addition to the phase 3 GLOW study, Janssen also announced that the phase 3 MAIA study evaluating Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) demonstrated superior overall survival (OS) compared to Rd alone. The study was conducted in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and received treatment until disease progression. A prespecified interim OS analysis revealed that after a median follow-up of 56.2 months, the Darzalex + Rd group achieved a 32% reduction in the risk of death compared to the Rd alone group. Janssen stated that median OS was not reached. Furthermore, after nearly five years of follow-up, median progression-free survival (PFS) was also not reached. The PFS benefit with the addition of Darzalex remained consistent, demonstrating a 47% reduction in the risk of disease progression or death. Data from this study are expected to support future regulatory submissions.

Source: Janssen Hits Two Phase III Marks in Hematology Presentations at EHA