Note to affiliates: This update to the venetoclax CLL AbbVie Pro site includes a homepage headline, updated CLL14 6-year, CLL13 4-year, MURANO 7-year data sets, and other streamlined content updates. CLL 13 4-year update reflects the CLL13 data from the Lancet Oncology publication. The CLL14 6-year and MURANO 7-year data have been updated based on the EHA 2023 abstracts. For countries that cannot use these data sets, please follow local regulations and MRLO guidance, and revert to CLL14 5-year and MURANO 5-year published data from the product label.
Primary analysis in ITT population for VEN+O vs O+Clb1:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]).
| • | Median follow-up of 28 months |
Additional analyses:
6-year PFS estimate (INV-assessed)2‡: 53% vs 22% (HR=0.40; 95% CI: 0.31–0.52) after 5 years off treatment.
| • | Median PFS of 76.2 months with VEN+O vs 36.4 months with O+Clb |
INV-assessed complete remission (CR/CRi)1: 50% vs 23% (P<0.0001).
| • | ORR: 85% (95% CI: 79.2–89.2) vs 71% (95% CI: 64.8–77.2 [P=0.0007]) |
Primary analysis in ITT population for VEN+R vs BR1:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]).
| • | Median follow-up of 23.8 months |
Additional analyses:
7-year PFS estimate (INV-assessed)3‡: 23% (HR=0.23; 95% CI: 0.18–0.29) vs NE after ~5 years off treatment.
| • | Median PFS of 54.7 months with VEN+R (95% CI: 52.3–59.9) vs 17.0 months with BR (95% CI: 15.5–21.7) |
INV-assessed complete remission (CR/CRi)1‡: 27% vs 8%.
| • | ORR: 93% (95% CI: 88.8–96.4) vs 68% (95% CI: 60.6–74.2) |
*See full dosing information for VEN+O and for VEN+R in the dosing and administration section.
†Primary endpoint.
‡Results are descriptive only.
1L=first line; CLL=chronic lymphocytic leukaemia; VEN+O=VENCLYXTO + obinutuzumab; ITT=intent to treat; O+Clb=obinutuzumab + chlorambucil; INV=investigator; PFS=progression-free survival; HR=hazard ratio; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete bone marrow recovery; ORR=overall response rate; 2L+=second line + later lines of therapy; VEN+R=VENCLYXTO + rituximab; BR=bendamustine + rituximab; NE=not evaluable.
ΘΕΜΑΤΑ ΕΝΔΙΑΦΕΡΟΝΤΟΣ ΣΧΕΤΙΚΑ ΜΕ ΤΗΝ ΑΣΦΑΛΕΙΑ1
Διακοπές της θεραπείας, μειώσεις της δοσολογίας και προσωρινές διακοπές της θεραπείας
ΔΙΑΚΟΠΕΣ ΤΗΣ ΘΕΡΑΠΕΙΑΣ, ΜΕΙΩΣΕΙΣ ΣΤΗ ΔΟΣΟΛΟΓΙΑ ΚΑΙ ΠΡΟΣΩΡΙΝΕΣ ΔΙΑΚΟΠΕΣ ΤΗΣ ΘΕΡΑΠΕΙΑΣ ΛΟΓΩ ΑΝΕΠΙΘΥΜΗΤΩΝ ΕΝΕΡΓΕΙΩΝ ΣΤΙΣ ΜΕΛΕΤΕΣ CLL14 ΚΑΙ MURANO
| • | Η πιο συχνή ανεπιθύμητη ενέργεια που οδήγησε στην προσωρινή διακοπή της θεραπείας του VENCLYXTO® ήταν η ουδετεροπενία, 41% και 43% στις μελέτες CLL14 και MURANO, αντίστοιχα. |
| • | Το 2% και το 3% των ασθενών σταμάτησαν τη θεραπεία με VENCLYXTO® λόγω της ουδετεροπενίας στις μελέτες CLL14 και MURANO αντίστοιχα |
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θεραπείες πεπερασμένης διάρκειας
ΠΑΡΑΠΟΜΠΕΣ: 1. VENCLYXTO® Περίληψη Χαρακτηριστικών του Προϊόντος (ΠΧΠ), Αύγουστος 2023.