{"id":373731,"date":"2024-01-16T11:36:11","date_gmt":"2024-01-16T10:36:11","guid":{"rendered":"https:\/\/medizinonline.com\/one-year-of-first-line-therapy-for-cll-for-the-prospect-of-more-than-5-years-of-treatment-freedom%c2%b9\/"},"modified":"2024-01-16T11:38:57","modified_gmt":"2024-01-16T10:38:57","slug":"one-year-of-first-line-therapy-for-cll-for-the-prospect-of-more-than-5-years-of-treatment-freedom%c2%b9","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/one-year-of-first-line-therapy-for-cll-for-the-prospect-of-more-than-5-years-of-treatment-freedom%c2%b9\/","title":{"rendered":"One year of first-line therapy for CLL for the prospect of more than 5 years of treatment freedom\u00b9"},"content":{"rendered":"\n

The BCL2 inhibitor venetoclax has been approved in Switzerland as a first-line therapy for chronic lymphocytic leukemia (CLL) since November 16, 2023 [2]. This is based on the results of the CLL14 study, the 6-year data of which were presented at the European Hematology Association Congress <\/em>in Frankfurt on June 9, 2023 [1]. The data give CLL patients the prospect of more than 5 years of treatment freedom after less than one year of combined treatment with venetoclax<\/strong> and obinutuzumab [1, 2].<\/strong><\/p>\n\n\n\n

The combination of chlorambucil (Clb) + obinutuzumab (Obi) was considered the standard of care in the first-line treatment of CLL, but the BCL2 inhibitor Venclyxto\u00ae (Ven) has also shown good efficacy in the past in second-line treatment after at least one prior treatment [3, 4]. In the randomized, multicenter, open-label Phase III CLL14 study, first-line treatment with Ven + Obi was tested in comparison to Clb + Obi over a fixed period of time in patients with previously untreated CLL and additional comorbidities. Ven + Obi showed a significant advantage in progression-free survival (PFS) [5]. Updated efficacy and safety data are now available from the ongoing follow-up of the CLL14 study, whereby at this point all patients have not received the study drug for \u2265 5 years [1].<\/p>\n\n

Consistently high PFS rates with Venclyxto\u00ae<\/h2>\n\n

A total of 432 patients with previously untreated CLL and additional comorbidities were included in the CLL14 study, with study participants randomized 1:1 to receive either 12 cycles of Ven with 6 cycles of Obi (Ven-Obi, n=216), or 12 cycles of Clb with 6 cycles of Obi (Clb-Obi, n=216) [1]. The median follow-up time in the updated follow-up study was 76.4 months (interquartile range 52.5-80.5) [1]. During follow-up, the median PFS in the Ven-Obi arm remained superior at 76.2 months compared to 36.4 months in the Clb-Obi arm (HR = 0.40; 95% CI [0,31-0,52], p<0.0001). The estimated PFS rate according to the investigators was 53.1 % in the Ven-Obi group and 21.7 % in the Clb-Obi arm 6 years after randomization [1].<\/p>\n\n

With Venclyxto\u00ae for long-lasting freedom from therapy<\/h2>\n\n

In the Ven-Obi group, 67 patients experienced disease progression (PD) and 39 second-line treatments, while 141 cases of PD occurred in the Clb-Obi group. 103 of these patients underwent second-line treatment [1]. The time to next treatment (TTNT) after 6 years of follow-up was 65.2 % in the Ven-Obi arm and 37.1 % after Clb-Obi (HR = 0.44; 95% CI [0,33-0,58], p<0.0001; Figure 1) [1]. Second-line treatment with Ven (monotherapy or in combination with rituximab) took place in 17.9% of patients after Ven-Obi and in 14.6% after Clb-Obi [1]. <\/p>\n\n

High survival rates even \u2265 5 years after the end of treatment<\/h2>\n\n

The 6-year overall survival rate was 78.7% after Ven-Obi treatment and 69.2% after Clb-Obi treatment (HR = 0.69; 95% CI [0,48-1,01], p=0.052), with 48 deaths in the Ven-Obi arm and 70 in the Clb-Obi arm [1]. Second primary malignancies were reported in 30 patients in the Ven-Obi arm and 18 in the Clb-Obi arm. <\/p>\n\n

Previous studies have shown no differences in tolerability between the two treatment regimens and no new safety signals have emerged even after 6 years of follow-up [1, 5]. The most common adverse events (\u2265 20%, all grades) in patients treated with Ven in the combination study with Obi were neutropenia, diarrhea and thrombocytopenia [1,2]. <\/p>\n\n

Conclusion<\/h2>\n\n

Overall, the updated data confirm a long-term PFS benefit of Ven-Obi treatment compared to Clb-Obi [1]. In addition, around 65% of patients treated with Ven-Obi still did not require second-line treatment \u2265 5 years after treatment, which underlines the long-term effect of the Ven-Obi first-line therapy regimen and allows patients valuable treatment-free time [1]. <\/p>\n\n

\n\t
\n\t\t\n\n

Areas of application of VENCLYXTO\u00ae<\/strong><\/p>\n\n\n\n

VENCLYXTO\u00ae in combination with obinutuzumab is approved for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL) and additional comorbidities [2]. VENCLYXTO\u00ae is approved in combination with rituximab in CLL patients after at least one prior therapy and is reimbursed by health insurance companies [2, 6]. VENCLYXTO\u00ae is also used as a monotherapy for CLL patients with a del(17p) or TP53 mutation following treatment failure with a B-cell receptor signaling pathway inhibitor. VENCLYXTO\u00ae is also available in combination with azacitidine, decitabine or low-dose cytarabine for adult patients with newly diagnosed acute myeloid leukemia (AML) for whom intensive chemotherapy is not an option [2].<\/p>\n\n\t<\/div>\n\t<\/div>\n\n

\"\"<\/figure>\n\n

Figure 1) <\/strong>Time to next anti-CLL treatment (TTNT) 5 years after end of therapy (EoT) with Venclyxto\u00ae+ obinutuzumab (Ven-Obi; yellow) and chlorambucil + obinutuzumab (Clb-Obi; gray). * 336 days in first-line therapy with Ven-Obi [2]. Adapted from Al Sawaf O. et al, 2023 [1]. <\/p>\n\n

Abbreviations<\/strong>: <\/p>\n\n

HR: Hazard Ratio; CI = Confidence Interval <\/p>\n\n

Brief technical information on VENCLYXTO\u00ae<\/a><\/p>\n\n

This article was produced with the financial support of AbbVie AG, Alte Steinhauserstrasse 14, Cham.<\/p>\n\n

CH-VNCLY-230063 11\/2023 <\/p>\n\n

Literature<\/p>\n\n

1 Al-Sawaf, O., et al, Venetoclax-Obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study. Abstract S145 (Oral). European Hematology Association Congress 2023, June 8-11 Frankfurt, Germany.<\/em>2. current technical information Venclyxto\u00ae<\/sup> <\/em>. \n www.swissmedicinfo.ch<\/em>\n<\/a>.<\/em>3 Eichhorst, B., et al, appendix 6: Chronic lymphocytic leukemia: eUpdate published online September 2016 (<\/em>\n http:\/\/www.esmo.org\/Guidelines\/Haematological-Malignancies<\/em>\n<\/a>).<\/em> Ann Oncol, 2016. 27<\/strong>(suppl 5): p. v143-v144.4 Fischer, K., et al, Venetoclax and obinutuzumab in chronic lymphocytic leukemia<\/em>. Blood, 2017. 129<\/strong>(19): p. 2702-2705.5 Fischer, K., et al, Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions<\/em>. N Engl J Med, 2019. 380<\/strong>(23): p. 2225-2236.6. Specialty list Venclyxto\u00ae<\/sup>. Federal Office of Public Health. <\/em>www.spezialitaetenliste.ch<\/em><\/a>. Status of the information: 06.07.2023.<\/em><\/p>\n\n

The references can be requested by professionals at medinfo.ch@abbvie.com.<\/p>\n","protected":false},"excerpt":{"rendered":"

The BCL2 inhibitor venetoclax has been approved in Switzerland as a first-line therapy for chronic lymphocytic leukemia (CLL) since November 16, 2023 [2]. This is based on the results of…<\/p>\n","protected":false},"author":14,"featured_media":373736,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Chronic lymphocytic leukemia (CLL)","footnotes":""},"category":[11370,11323,11548],"tags":[52654,36040],"powerkit_post_featured":[],"class_list":["post-373731","post","type-post","status-publish","format-standard","has-post-thumbnail","category-oncology","category-partner-content-en","category-rx-en","tag-lymphatic-leukemia","tag-oncology","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-06-11 02:02:09","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":373732,"slug":"un-an-de-traitement-de-premiere-ligne-de-la-llc-pour-une-perspective-de-plus-de-5-ans-dabsence-de-traitement%c2%b9","post_title":"Un an de traitement de premi\u00e8re ligne de la LLC pour une perspective d'une absence de traitement pendand plus de 5 ans\u00b9","href":"https:\/\/medizinonline.com\/fr\/un-an-de-traitement-de-premiere-ligne-de-la-llc-pour-une-perspective-de-plus-de-5-ans-dabsence-de-traitement%c2%b9\/"},"it_IT":{"locale":"it_IT","id":373733,"slug":"un-anno-di-terapia-di-prima-linea-per-la-llc-con-la-prospettiva-di-piu-di-5-anni-di-liberta-dal-trattamento%c2%b9","post_title":"Un anno di terapia di prima linea per la LLC con la prospettiva di pi\u00f9 di 5 anni di libert\u00e0 dal trattamento\u00b9.","href":"https:\/\/medizinonline.com\/it\/un-anno-di-terapia-di-prima-linea-per-la-llc-con-la-prospettiva-di-piu-di-5-anni-di-liberta-dal-trattamento%c2%b9\/"},"pt_PT":{"locale":"pt_PT","id":373734,"slug":"um-ano-de-terapeutica-de-primeira-linha-para-a-llc-na-perspetiva-de-mais-de-5-anos-de-liberdade-de-tratamento%c2%b9","post_title":"Um ano de terap\u00eautica de primeira linha para a LLC na perspetiva de mais de 5 anos de liberdade de tratamento\u00b9","href":"https:\/\/medizinonline.com\/pt-pt\/um-ano-de-terapeutica-de-primeira-linha-para-a-llc-na-perspetiva-de-mais-de-5-anos-de-liberdade-de-tratamento%c2%b9\/"},"es_ES":{"locale":"es_ES","id":373735,"slug":"un-ano-de-terapia-de-primera-linea-para-la-llc-ante-la-perspectiva-de-mas-de-5-anos-libres-de-tratamiento%c2%b9","post_title":"Un a\u00f1o de terapia de primera l\u00ednea para la LLC ante la perspectiva de m\u00e1s de 5 a\u00f1os libres de tratamiento\u00b9.","href":"https:\/\/medizinonline.com\/es\/un-ano-de-terapia-de-primera-linea-para-la-llc-ante-la-perspectiva-de-mas-de-5-anos-libres-de-tratamiento%c2%b9\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/373731","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=373731"}],"version-history":[{"count":1,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/373731\/revisions"}],"predecessor-version":[{"id":373738,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/373731\/revisions\/373738"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/373736"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=373731"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=373731"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=373731"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=373731"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}