dc.contributor.author | Collins, GP | |
dc.contributor.author | Eyre, TA | |
dc.contributor.author | Schmitz-Rohmer, D | |
dc.contributor.author | Townsend, W | |
dc.contributor.author | Popat, R | |
dc.contributor.author | Giulino-Roth, L | |
dc.contributor.author | Fields, PA | |
dc.contributor.author | Krasniqi, F | |
dc.contributor.author | Soussain, C | |
dc.contributor.author | Stathis, A | |
dc.contributor.author | Andjelkovic, N | |
dc.contributor.author | Cunningham, D | |
dc.contributor.author | Mandic, D | |
dc.contributor.author | Radulovic, S | |
dc.contributor.author | Tijanic, I | |
dc.contributor.author | Horowitz, NA | |
dc.contributor.author | Kurtovic, S | |
dc.contributor.author | Schorb, E | |
dc.contributor.author | Schmidt, C | |
dc.contributor.author | Dimitrijević, S | |
dc.contributor.author | Dreyling, M | |
dc.date.accessioned | 2022-01-07T14:07:12Z | |
dc.date.available | 2022-01-07T14:07:12Z | |
dc.date.issued | 2021-11-01 | |
dc.identifier.citation | HemaSphere, 2021, 5 (11), pp. e656 - ? | |
dc.identifier.issn | 2572-9241 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4950 | |
dc.identifier.eissn | 2572-9241 | |
dc.identifier.doi | 10.1097/hs9.0000000000000656 | |
dc.description.abstract | Bimiralisib is an orally bioavailable pan-phosphatidylinositol 3-kinase and mammalian target of rapamycin inhibitor which has shown activity against lymphoma in preclinical models. This phase I/II study evaluated the response rate to bimiralisib at 2 continuous dose levels (60 mg and 80 mg) in patients with relapsed/refractory lymphoma. Fifty patients were enrolled and started treatment. The most common histologies were diffuse large B-cell lymphoma (n = 17), follicular lymphoma (n = 9), T-cell lymphoma (n = 8), and others (mostly indolent). Patients had been treated with a median of 5 prior lines of treatment and 44% were considered refractory to their last treatment. Mean duration of treatment (and standard deviations) with 60 mg once daily (o.d.) was 1.3 ± 1.2 months, and with 80 mg o.d. 3.7 ± 3.9 months. On an intention to treat analysis, the overall response rate was 14% with 10% achieving a partial response and 4% a complete response. Thirty-six percent of patients were reported as having stable disease. No dose-limiting toxicities were observed during the phase I portion of the study. Overall, 70% of patients had a grade 3 treatment emergent adverse events (TEAE) and 34% had a grade 4 TEAE; 28% of patients discontinued treatment due to toxicity. The most frequent TEAEs grade ≥3 was hyperglycemia (24%), neutropenia (20%), thrombocytopenia (22%), and diarrhea (12%). Per protocol, hyperglycemia required treatment with oral antihyperglycemic agents in 28% and with insulin in 14%. At 60 mg or 80 mg continuous dosing, bimiralisib showed modest efficacy with significant toxicity in heavily pretreated patients with various histological subtypes of lymphoma. | |
dc.format | Electronic-eCollection | |
dc.format.extent | e656 - ? | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | WILEY | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.title | A Phase II Study to Assess the Safety and Efficacy of the Dual mTORC1/2 and PI3K Inhibitor Bimiralisib (PQR309) in Relapsed, Refractory Lymphoma. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-10-07 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1097/hs9.0000000000000656 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | HemaSphere | |
pubs.issue | 11 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 5 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Medicine (RMH Smith Cunningham) | |
dc.contributor.icrauthor | Cunningham, David | |