Johnson&Johnson FGFR kinase inhibitor Balversa ua ke nrog PD-1 inhibitor cetrelimab--1/2

Janssen Pharmaceuticals, ib lub koom haum ntawm Johnson& Johnson (JNJ), tsis ntev los no tau tshaj tawm cov txiaj ntsig ntawm Phase 1b/2 NORSE txoj kev tshawb fawb (NCT03473743) ntawm 2021 European Society of Medical Oncology (ESMO) lub rooj sib tham virtual. Txoj kev tshawb no yog ua nyob rau hauv cov neeg mob uas nyob rau hauv lub zos advanced los yog metastatic urothelial carcinoma (mUC) uas tsis haum rau cisplatin chemotherapy thiab nqa fibroblast loj hlob yam receptor (FGFR) FGFR3 los yog FGFR2 noob hloov. FGFR kinase inhibitor Balversa (erdafitinib) thiab PD-1 inhibitor cetrelimab ua ke txoj kev kho mob, thiab piv nrog Balversa ib leeg-tus neeg saib xyuas txoj kev npaj kho mob. Cisplatin tam sim no yog tus qauv kev kho mob rau kev kho mob ntawm mUC.

Cov txiaj ntsig kev tshawb fawb ua ntej qhia tau hais tias Balversa +cetrelimab kev tswj hwm tau pom muaj zog kho mob thiab qhov tob ntawm kev nyem rau cov neeg mob, thiab nws txoj kev nyab xeeb tag nrho yog feem ntau zoo ib yam nrog Balversa monotherapy, thiab yog piv rau qhov paub txog kev nyab xeeb ntawm kev pom zoo anti-PD -1 kev kho mob. Kev sib koom siab.

Thaum lub sijhawm tshuaj xyuas cov ntaub ntawv, ntawm 19 tus neeg mob uas tau txais Balversa+ kev kho cetrelimab, lub hom phiaj teb tus nqi (ORR) ntsuas los ntawm tus kws tshawb fawb soj ntsuam yog 68% (95% CI: 43-87), ntawm 21. %. Cov qauv kev ntsuam xyuas cov lus teb ntawm tus qauv kev ntsuam xyuas cov qog ua tau zoo version 1.1 (RECIST v1.1) tau siv rau kev ntsuam xyuas, thiab tus nqi tswj tus kab mob (DCR) yog 90% (95% CI: 67-99). Ntawm 18 tus neeg mob tau txais Balversa monotherapy, ORR yog 33% (95% CI: 13-59), ntawm 1 tus neeg mob yog CR, 28% (n=5) yog PR, thiab DCR yog 100% (95%) CI : 82–100).

Hauv txoj kev tshawb no, kev nyab xeeb ntawm Balversa ua ke nrog kev kho cetrelimab (n=24) yog qhov pib zoo ib yam li Balversa monotherapy (n=24). Feem ntau cov kev kho mob-lub sij hawm tsis zoo tshwm sim (AE) yog hyperphosphatemia (Balversa+ Cetrelimab pawg vs Balversa monotherapy pawg: 58% vs 58%), stomatitis (54% vs 63%), raws plab (42% vs 50% ), qhov ncauj qhuav (58% vs 21%), tawv nqaij qhuav (38%) vs 21%) thiab anemia (25% vs 25%). Qib 3-4 cov xwm txheej tsis zoo tshwm sim hauv 12 tus neeg mob (50%) hauv Balversa+cetrelimab pawg thiab 9 tus neeg mob (38%) hauv pawg Balversa ib tus neeg sawv cev. Qib 3-4 feem ntau tshwm sim tsis zoo hauv Balversa+cetrelimab pawg yog stomatitis (n=3[12.5%)), lipase siab (n=3[12.5%)) thiab qaug zog (n=2[8.3] %]]); Hauv pawg Balversa, nws yog anemia (n=3 [12.5%) thiab kev noj qab haus huv ntawm lub cev (n=3[12.5%)).

Tus thawj coj ntawm kev tshawb fawb, Thomas Powles, tus kws tshaj lij ntawm urological oncology, tus thawj coj ntawm Barts Cancer Institute hauv London, tau hais tias:" PD-1 inhibitors tau dhau los ua kev kho mob rau ntau hom qog nqaij hlav, nrog rau mob qog noj ntshav. . Tam sim no, raws li peb cuam tshuam qhov cuam tshuam Kom nkag siab txog cov caj ces ntawm cov txiaj ntsig kev kho mob, peb tab tom tshawb nrhiav cov kev kho tshiab uas yuav pab tau cov neeg mob muaj kev hloov pauv tshwj xeeb, suav nrog FGFR hloov pauv thiab fusions. Los ntawm Balversa thiab cetrelimab ua ke kev kho mob, peb tsom mus hloov cov qog microenvironment thiab ua kom yooj yim cuam tshuam los ntawm PD-1."