Janssen presented the Phase III Glow study for the elderly with CLL or SLL and the overall survival results from the Phase III MAIA study for patients with NDMM.
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Johnson & Johnson’s Imbruvica combined with Genentech’s Venclexta (venetoclax) hit the mark in the Phase III GLOW study assessing the combination as a first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The study conducted by Janssen, a subsidiary of Johnson & Johnson, compared the combination treatment to chlorambucil plus obinutuzumab (Clb+O) in this patient population. Data showed that the orally-administered Imbruvica plus Venclexta demonstrated superior progression-free survival (PFS) compared to the infusion regimen of the other combination.
Additionally, the study showed Imbruvica plus Venclexta provided an improved duration of remission and significantly improved depth of remission in the patient population. Data from the Phase III study was presented at the ongoing European Hematology Association conference.
Craig Tendler, vice president of Late Development and Global Medical Affairs in Oncology at Janssen Research & Development, said Imbruvica and Venclexta have complementary mechanisms of action. Results from the GLOW study and the Phase II CAPTIVATE study show that the oral regimen can provide an effective and flexible treatment option for patients with these disease types.
Across the two studies, Tendler said more than 400 patients had received the combination therapy, which demonstrates the potential of Imbruvica in this regimen across multiple patient groups.
“The data from GLOW showed that Imbruvica in an oral, once-daily fixed-duration combination with venetoclax outperformed a standard chemo-immunotherapy regimen for older or unfit patients, providing the first comparative evidence that this approach has the potential to improve depth of response and, therefore, extends time to progression versus standard therapy,” Arnon Kater deputy head of hematology at the University of Amsterdam Faculty of Medicine in the Netherlands and principal study investigator said in a statement.
At a median follow-up of 27.7 months, an independent review committee found the Imbruvica and Venclexta combination provided superior progression-free survival results than Clb+O. Johnson & Johnson said the improvement in progression-free survival was consistent across predefined subgroups, including older patients and patients with higher comorbidity scores.
That wasn’t the only positive news coming out of the EHA for Janssen. In addition to the Phase III GLOW study, Janssen announced that overall survival results from the Phase III MAIA study assessing the addition of Darzalex (daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over Rd alone.
The study was conducted in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression. Data from the MAIA study was also presented at EHA.
The prespecified interim analysis for OS found that after a median follow-up of 56.2 months, a 32 percent% in the risk of death was observed in the Darzalex plus Rd arm compared to Rd alone. Janssen said median OS was not reached. Also, median progression-free survival was not reached after nearly five years of study.
The PFS benefit observed with the addition of Darzalex was maintained, with a 47% reduction in risk of disease progression or death. Data from this study is expected to support a future regulatory filing.
Tendler stated that the MAIA findings demonstrate the impact of this Darzalex combination regimen on long-term survival in the frontline setting. He said it further establishes the importance of Darzalex as a backbone therapy in multiple myeloma.
“These results provide hope and confidence for newly diagnosed patients with multiple myeloma seeking effective treatment regimens that improve long-term outcomes and reflect our commitment to continuing to explore the full potential of Darzalex in multiple myeloma,” Tendler said.
