AstraZeneca

AMPLIFY Phase III trial results show AstraZeneca’s Calquence combined with venetoclax significantly improves progression-free survival in untreated chronic lymphocytic leukaemia patients, reducing progression risk by 35% compared to chemoimmunotherapy. The combination with obinutuzumab reduced risk by 58%. Median PFS was not reached for experimental arms versus 47.6 months for chemoimmunotherapy. Interim OS data showed a favorable trend, with the trial continuing to assess OS.

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CALQUENCE plus venetoclax with obinutuzumab reduced the risk of disease progression or death by 58% versus standard of care in previously untreated adult patients with chronic lymphocytic leukemia (CLL). CALQUENCE plus venetoclax demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy.

CALQUENCE safety consistent with known profile; no new safety signals. Grade 3+ AEs: 53.6% (CALQUENCE + venetoclax), 69.4% (with obinutuzumab), 60.6% (chemoimmunotherapy). Most common Grade 3+ AE: neutropenia. Low TLS rates observed in CALQUENCE arms (0.3% and 0.4%) vs. 3.1% (chemoimmunotherapy). No clinical TLS cases. CALQUENCE used in >85,000 patients worldwide; approved for CLL/SLL in US, Japan, EU, China.

CALQUENCE plus venetoclax reduced CLL progression/death risk by 35% vs. chemoimmunotherapy at 41 months follow-up. CALQUENCE plus venetoclax with obinutuzumab showed a 58% reduction. Median PFS not reached for experimental arms vs. 47.6 months for chemoimmunotherapy. OS trend favorable for CALQUENCE plus venetoclax (HR 0.33; p<0.0001).

Calquence plus venetoclax showed superior PFS in previously untreated CLL, reducing progression risk by 58% vs. standard care in AMPLIFY Phase III trial. This all-oral fixed-duration regimen could offer new treatment flexibility for patients.

Calquence (acalabrutinib) is a selective BTK inhibitor approved for mantle cell lymphoma (MCL) in the US and China. AstraZeneca is expanding its haematology pipeline through acquisitions and focusing on oncology to redefine cancer care.

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