{"id":4067,"date":"2026-11-04T09:00:00","date_gmt":"2026-11-04T13:00:00","guid":{"rendered":"https:\/\/www.insilens.com\/?p=4067"},"modified":"2026-11-04T21:49:27","modified_gmt":"2026-11-05T01:49:27","slug":"tambiciclib-triplet-shows-preliminary-activity-after-venetoclax-failure","status":"publish","type":"post","link":"https:\/\/www.insilens.com\/?p=4067","title":{"rendered":"Tambiciclib Triplet Shows Preliminary Activity After Venetoclax Failure"},"content":{"rendered":"

\"\"<\/p>\n

Company<\/strong><\/p>\n

SELLAS Life Sciences<\/p>\n

Event Type<\/strong><\/p>\n

Phase 2 data disclosure<\/p>\n

Modality<\/strong><\/p>\n

Small molecule<\/p>\n

Asset<\/strong><\/p>\n

Tambiciclib (SLS009) with azacitidine and venetoclax<\/p>\n

Target<\/strong><\/p>\n

CDK9<\/p>\n

Disease Area<\/strong><\/p>\n

Relapsed or refractory AML<\/p>\n

Summary<\/h4>\n

SELLAS disclosed Phase 2 results on November 4 for tambiciclib (SLS009) with azacitidine and venetoclax in relapsed or refractory AML after prior venetoclax. This is a numerical data disclosure ahead of a December poster, not merely an ASH presentation notice.<\/p>\n

Sixty-two patients were treated in the dose-ranging study; 59 were efficacy-evaluable. Across doses, objective response was 34%, comprising 12 CR\/CRi and eight morphologic leukemia-free states. At the selected 30 mg twice-weekly dose, the company reported 54% response and 5.8-month median overall survival in monocytic AML and 57% response and 8.8-month median overall survival in TP53-mutated AML. The selected-dose subgroup denominators were not provided in the disclosure.<\/p>\n

Deep Analysis<\/h4>\n

Interpretation A:<\/strong> CDK9 inhibition may weaken MCL1-dependent survival and resensitize some venetoclax-exposed AML to the azacitidine\/venetoclax backbone. Responses in adverse-risk phenotypes support testing this mechanism. Counterargument: the study is open-label and noncomparative; prior therapies, subgroup selection, and small unknown denominators undermine comparisons with historical 2.5-month survival.<\/p>\n

Interpretation B:<\/strong> some activity may reflect re-exposure to azacitidine\/venetoclax or patient selection rather than the CDK9 contribution. Biomarker-correlated pharmacodynamics and a controlled cohort would distinguish this. The next decisive evidence is full patient-level duration, transfusion and infection burden, grade 3\u20135 cytopenias, dose intensity, and randomized survival.<\/p>\n

Company and Product Background<\/h4>\n

SELLAS develops tambiciclib, a small-molecule CDK9 inhibitor. CDK9 regulates transcription of short-lived survival proteins including MCL1. AML is an aggressive myeloid malignancy; venetoclax resistance remains a major problem after frontline combination therapy.<\/p>\n

Signal Extraction<\/h4>\n
    \n
  • The sponsor describes tolerability as acceptable and claims little additive toxicity, but complete adverse-event tables were not in this release.<\/li>\n
  • A newly diagnosed AML cohort is enrolling; its expected Q4 data are future guidance.<\/li>\n<\/ul>\n

    InSilens Take<\/h4>\n

    The post-venetoclax response signal warrants study, especially in molecularly adverse AML. It does not establish reversal of resistance or superiority to salvage options.<\/p>\n

    Signal Assessment<\/h4>\n

    Signal Importance: 4 of 5. Signal Direction: cautiously positive for observed responses, uncertain for comparative efficacy. Confidence in Facts: moderate for company-reported counts. Confidence in Interpretation: low-moderate given nonrandomized design and undisclosed subgroup sizes.<\/p>\n","protected":false},"excerpt":{"rendered":"

    SELLAS disclosed Phase 2 results on November 4 for tambiciclib (SLS009) with azacitidine and venetoclax in relapsed or refractory AML after prior venetoclax. This is a numerical data disclosure ahead of a December poster,…<\/p>\n","protected":false},"author":1,"featured_media":4077,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[76,1361,1362],"class_list":["post-4067","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-therapeutic-indication","tag-acute-myeloid-leukemia","tag-sellas-life-sciences","tag-tambiciclib"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/4067","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4067"}],"version-history":[{"count":1,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/4067\/revisions"}],"predecessor-version":[{"id":4085,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/4067\/revisions\/4085"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/media\/4077"}],"wp:attachment":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4067"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4067"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4067"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}