New AMPLIFY data shows Calquence's fixed-duration promise in CLL treatments

AstraZeneca announced promising results from a Phase III study that suggest a shift in the use of its BTK inhibitor, Calquence (acalabrutinib), in treating chronic lymphocytic leukaemia (CLL). The study explored combining Calquence with AbbVie and Roche’s BCL-2 inhibitor, Venclexta/Venclyxto (venetoclax). The AMPLIFY trial focused on adults with previously untreated CLL who lack del(17p) or TP53 mutations. Participants were assigned to receive either a combination of Calquence and Venclexta/Venclyxto, with or without Roche’s Gazyva/Gazyvaro (obinutuzumab), or standard chemoimmunotherapy, all for a fixed duration.

Interim analysis revealed that the combination of Calquence and Venclexta/Venclyxto significantly improved progression-free survival (PFS) compared to the traditional chemoimmunotherapy, meeting the study’s main objective. Furthermore, the regimen that included Gazyva/Gazyvaro also demonstrated a notable and statistically significant improvement in PFS, achieving another crucial secondary aim of the trial.

AstraZeneca highlighted that early data showed an encouraging trend in overall survival (OS) favoring the Calquence-based regimens, though the data were not fully mature. The study will continue to monitor OS as a secondary endpoint. Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D, emphasized that these results highlight the potential for incorporating a BTK inhibitor in a fixed-duration treatment plan. She pointed out that, if approved, Calquence could become the only second-generation BTK inhibitor available for both treat-to-progression and fixed-duration use.

The detailed findings from the AMPLIFY trial are set to be presented at an upcoming medical conference and will be shared with regulatory bodies. Currently, Calquence is approved for treating CLL, small lymphocytic lymphoma (SLL), and mantle cell lymphoma.