Bayer copanlisib Unilitoxy monoantitherapy iNHL significantly extends patient PFS.

On October 14, Bayer announced the results of a Phase 3 clinical study, CHRONOS-3.
the trial evaluated the treatment of relapse painless non-Hodgkin's lymphoma (iNHL) with copanlisib unilphase (rituximab) - including follicle lymphoma (FL), marginal lymphoma (MZL), small lymphocyte lymphoma (SLL) and lymphocyte-like lymphoma/Waldenstrome globulinemia (LPL/WM).
results of the study showed that the combination therapy had reached the main endpoint of significantly prolonging progress-free survival (PFS).
same time, the safety and tolerance observed in the trials were usually consistent with previously published data on the components of the combined drug, and no new safety signals were found.
CHRONOS-3 is a Phase 3 randomized, double-blind, placebo-controlled study (NCT02367040).
study, the patient's histological subsypes included FL, SLL, LPL/WM, and MZL, and the patients in the group must use lyxi monosimilars, lysoxi monosimilars, or anti-CD20 monoclonal antibodies (e.g., Obinyuto bead monoantibodies, obin utuzumab) relapses after treatment (other treatment lines after lyxix monotherapy is also permitted) and there is a ≥12-month non-treatment interval after the last treatment with lyxix monoantigen, or patients who are unwilling to receive chemotherapy or are prohibited due to age, cogeneration and/or residual toxicity.
study eventually recruited 458 participants, randomly grouped by a 2:1 ratio.
The patient was given Copanlisib on the first, 8th and 15th days of the treatment cycle every 28 days, and lytoxisi monotherapy on the 1st, 8th, 15th and 22nd days of the 1st treatment cycle;
study was expected to be observed for 59 months, with the primary endpoint being the time when patients died from random grouping to disease progression or any cause, i.e. PFS;
Copanlisib is an intravenous pan-I. phosphatidyl inositol-3 kinase (PI3K) inhibitor that is active against PI3K alpha and PI3K isomers expressed in malignant B cells.
that it can induce tumor cell death by apoptosis and inhibiting the proliferation of primary malignant B-cell line.
Copanlisib Molecular Structure (Source: Wikipedia) The drug has been approved in the United States under the Accelerated Approval Pathway to treat adult patients with relapsed follicle lymphoma (FL) who have received at least two systemic treatments.
The accelerated approval of the condition was based on the results of an open-label single-arm Phase 2 clinical study, CHRONOS-1 (NCT01660451), which evaluated 104 patients with adult follicle B cell NHL who had relapsed or were difficult to treat after at least two previous systemic therapies.
, the overall mitigation rate (ORR) was 59 per cent, with a CR rate of 14 per cent.
, the American Journal of Hematology 2020 published the latest CHRONOS-1 data showing that the FL population had 59% ORR, of which CRs were 20%.
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