Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Efficacy and Safety of Capivasertib (AZD5363), a Potent, Oral Pan-AKT Inhibitor, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL).
СтатьяМногоцентровое исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Hodson Daniel J, Shouse Geoffrey, Shin Ho-Jin, Salar Antonio, Bobillo Sabela, Ribrag Vincent, Macpherson Nicol A, Cordoba Raul, Kim Jin Seok, Guidez Stephanie, Herrera Alex F, Morschhauser Franck, Colton Dachelle, Izuzquiza Macarena, Sambamurthy Nisha, Munugalavadla Veerendra, Vicente Sergio, Gorgun Gullu, Chen Robert, Younes Anas, Wang Michael L
Аннотация
PURPOSE: An unmet treatment need remains for relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), including the follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) subtypes. The PI3K/AKT/mTOR pathway is dysregulated and associated with poor prognosis in NHL. The AKT inhibitor capivasertib has preclinical activity in hematologic malignancy models.
PATIENTS AND METHODS: NCT05008055 was a modular, open-label, multicenter phase II study that examined oral capivasertib monotherapy in patients with R/R B-cell NHL who had received ≥2 prior lines of therapy. Patients had R/R FL (cohort 1A), MZL (cohort 1B), or MCL (cohort 1C). Capivasertib 480 mg twice daily was administered orally 4 days on/3 days off. The primary objective was to determine the objective response rate (ORR) by blinded independent central review.
RESULTS: Thirty patients were enrolled (of 272 planned). The ORR for patients with R/R FL, MZL, and MCL were 18.8% (three of 16), 33.3% (one of three), and 30% (three of 10), respectively; 62.5% (10 of 16) of patients with R/R FL had stable disease. Baseline tumor PTEN expression was deficient/undetectable in the two patients who had a complete response and three of five patients who had a partial response. The most common capivasertib-related adverse events (AE) were diarrhea (63.3%), nausea (20%), vomiting (13.3%), and hyperglycemia (10%). Capivasertib-related grade ≥3 AE or serious AE were observed in nine and three patients, respectively.
CONCLUSIONS: The study was terminated early with a small sample size, limiting interpretation, although antitumor activity was limited. Future studies of capivasertib in hematologic malignancies would likely require biomarker-directed patient selection and/or combination therapy.
PATIENTS AND METHODS: NCT05008055 was a modular, open-label, multicenter phase II study that examined oral capivasertib monotherapy in patients with R/R B-cell NHL who had received ≥2 prior lines of therapy. Patients had R/R FL (cohort 1A), MZL (cohort 1B), or MCL (cohort 1C). Capivasertib 480 mg twice daily was administered orally 4 days on/3 days off. The primary objective was to determine the objective response rate (ORR) by blinded independent central review.
RESULTS: Thirty patients were enrolled (of 272 planned). The ORR for patients with R/R FL, MZL, and MCL were 18.8% (three of 16), 33.3% (one of three), and 30% (three of 10), respectively; 62.5% (10 of 16) of patients with R/R FL had stable disease. Baseline tumor PTEN expression was deficient/undetectable in the two patients who had a complete response and three of five patients who had a partial response. The most common capivasertib-related adverse events (AE) were diarrhea (63.3%), nausea (20%), vomiting (13.3%), and hyperglycemia (10%). Capivasertib-related grade ≥3 AE or serious AE were observed in nine and three patients, respectively.
CONCLUSIONS: The study was terminated early with a small sample size, limiting interpretation, although antitumor activity was limited. Future studies of capivasertib in hematologic malignancies would likely require biomarker-directed patient selection and/or combination therapy.