biotech · Duchenne Muscular Dystrophy · Duchenne muscular dystrophy · SLDB
Solid Biosciences is a biotech organization headquartered in Boston, USA. It trades on NYSE under ticker SLDB. Primary therapeutic focus areas include Duchenne Muscular Dystrophy, Duchenne muscular dystrophy, Glioblastom
Phase 2 · small molecule · Glioblastoma
Bevacizumab/Irinotecan (CRCST-L-0006) is a combination therapy program developed by Solid Biosciences targeting glioblastoma, an aggressive primary brain malignancy. The program combines bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor approved globally, with irinotecan, a topoisomerase I inhibitor. T
Internal code CRCST-L-0006
Bevacizumab/Irinotecan (CRCST-L-0006) is a combination therapy program developed by Solid Biosciences targeting glioblastoma, an aggressive primary brain malignancy. The program combines bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor approved globally, with irinotecan, a topoisomerase I inhibitor. The Phase 2 trial (NCT00921167) was completed as of December 2013. Bevacizumab is administered intravenously and is classified as an antineoplastic and immunomodulating agent. The program represents a combination approach to address the high unmet medical need in glioblastoma, where prognosis remains poor despite standard-of-care temozolomide and radiation therapy. Bevacizumab itself has achieved regulatory approval across major markets: FDA approval (BLA125085), EMA approval with multiple marketing authorization holders, PMDA approval in Japan (April 2007, May 2016), and TGA approval in Australia with multiple sponsors including Amgen Australia, Celltrion Healthcare Australia, and Sandoz. The combination strategy leverages bevacizumab's anti-angiogenic mechanism with irinotecan's cytotoxic activity to potentially improve outcomes in this difficult-to-treat indication. No further development milestones or regulatory actions have been disclosed since the Phase 2 completion in December 2013.
Glioblastoma remains one of the most lethal human malignancies with median overall survival of approximately 15 months despite multimodal therapy. The unmet medical need is substantial, as current standard-of-care treatment with temozolomide and radiation provides limited survival benefit and most patients develop recurrent disease. The bevacizumab/irinotecan combination addresses this need by targeting tumor angiogenesis (a hallmark of glioblastoma pathology) while delivering cytotoxic chemotherapy. Bevacizumab has demonstrated clinical activity in recurrent glioblastoma in prior studies, making this combination rationally designed. The market for glioblastoma therapeutics remains limited but clinically significant given the disease's aggressive nature and poor prognosis. Competitive positioning against other antineoplastic agents is relevant, though the specific competitive set for glioblastoma differs from the broader oncology landscape. The patient population, while smaller than many solid tumors, represents a highly motivated treatment-seeking cohort with few effective options. Commercial significance is tempered by the relatively small patient population but elevated by the critical unmet need and potential for premium pricing in orphan/rare disease settings. The program's completion status and lack of recent milestones suggest either transition to later-stage development, commercial evaluation, or discontinuation—details not disclosed in available records.
Drug Class: Antineoplastic and immunomodulating agents (ATC L01)
Modality: Small molecule (irinotecan) combined with monoclonal antibody (bevacizumab)
Route of Administration: Intravenous
Mechanism of Action: Bevacizumab is a VEGF inhibitor that blocks tumor angiogenesis; irinotecan is a topoisomerase I inhibitor that induces DNA damage and apoptosis
Target: VEGF pathway (bevacizumab); topoisomerase I (irinotecan)
Also known as: GBM, GBM (glioblastoma), WHO grade IV glioma, glioblastoma (disease), glioblastoma multiforme, glioblastoma multiforme (disease)
Prevalence: Point prevalence: 1-9 / 100 000 (Worldwide) — source: Orphanet, validated.
The most malignant astrocytic tumor (WHO grade IV). It is composed of poorly differentiated neoplastic astrocytes and it is characterized by the presence of cellular polymorphism, nuclear atypia, brisk mitotic activity, vascular thrombosis, microvascular proliferation and necrosis. It typically affects adults and is preferentially located in the cerebral hemispheres. It may develop from diffuse astrocytoma WHO grade II or anaplastic astrocytoma (secondary glioblastoma, IDH-mutant), but more frequently, it manifests after a short clinical history de novo, without evidence of a less malignant precursor lesion (primary glioblastoma, IDH- wildtype). (Adapted from WHO)
ClinicalTrials.gov lists 877 registered studies for Glioblastoma (AACT aggregate).
Phase breakdown: NA (252), PHASE2 (223), PHASE1 (206), PHASE1/PHASE2 (86), EARLY_PHASE1 (49), PHASE3 (45), PHASE2/PHASE3 (11), PHASE4 (5)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0018177), Orphanet — glioblastoma, NCT00001148, NCT00001171, NCT00009035, NCT00028158, NCT00029783, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 2 trial completed
Bevacizumab/irinotecan Phase 2 trial (NCT00921167) in glioblastoma completed as of December 4, 2013.
The competitive landscape for glioblastoma therapeutics includes multiple approved antineoplastic agents, though most are not glioblastoma-specific. The facts list competitors including IMBRUVICA (ibrutinib, Janssen-Cilag), AFINITOR (everolimus, Novartis), INLYTA (axitinib, Pfizer), KYPROLIS (carfilzomib, Amgen), OFEV (nintedanib, Boehringer Ingelheim), and various chemotherapy agents. However, these competitors represent broader oncology approvals rather than glioblastoma-specific therapies. Bevacizumab itself competes with other anti-angiogenic approaches and has established clinical utility in recurrent glioblastoma. The bevacizumab/irinotecan combination differentiates through dual mechanism targeting both angiogenesis and DNA damage. Specific glioblastoma competitors not detailed in the facts likely include other VEGF inhibitors, checkpoint inhibitors, and novel targeted agents in development. The competitive positioning depends on efficacy data from the completed Phase 2 trial, which has not been disclosed in the available facts. Market consolidation and biosimilar competition for bevacizumab (with multiple EMA-approved biosimilars listed) may impact commercial viability of the combination approach.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| PFIZER AUSTRALIA PTY LTD | Pfizer Australia Pty Ltd | — | approved |
| IMBRUVICA | Janssen-Cilag Pty Ltd | — | approved |
| AFINITOR | Novartis Pharmaceuticals | — | approved |
| LYSODREN | S.A. | — | approved |
| INLYTA | Pfizer Australia Pty Ltd | — | approved |
| LYNOZYFIC | Regeneron UK Limited | — | approved |
| VYXEOS LIPOSOMAL (PREVIOUSLY VYXEOS) | Jazz Pharmaceuticals Ireland Limited | — | approved |
| KYPROLIS | Amgen | — | approved |
| UNITUXIN | United Therapeutics Europe Ltd | — | approved |
| PACLITAXEL ACCORD | Accord Healthcare Pty. | — | approved |
| OFEV | Boehringer Ingelheim Pty Ltd | — | approved |
| ARX-IMATINIB | Alphapharm Pty Ltd | — | approved |
| CARMUSTINE | — | Glutathione reductase inhibitor | Approved |
| BEVACIZUMAB | — | Vascular endothelial growth factor A inhibitor | Approved |
| TRABEDERSEN | — | Transforming growth factor beta-2 mRNA antisense inhibitor | Phase 3 |
| TOFACITINIB | — | Janus Kinase (JAK) inhibitor | Phase 3 |
| RINDOPEPIMUT | — | Epidermal growth factor receptor erbB1 vaccine antigen | Phase 3 |
| OMBIPEPIMUT-S | — | Wilms tumor protein vaccine antigen | Phase 3 |
| NIVOLUMAB | — | Programmed cell death protein 1 inhibitor | Phase 3 |
| NIMOTUZUMAB | — | Epidermal growth factor receptor erbB1 inhibitor | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
FDA (United States): Bevacizumab approved under BLA125085. Combination program regulatory status not yet disclosed.
EMA (European Union): Bevacizumab approved with 16 marketing authorization holders including Amgen Europe B.V., Roche Registration GmbH, Pfizer Europe MA EEIG, and multiple biosimilar manufacturers. EMA product numbers range from EMEA/H/C/000582 to EMEA/H/C/006392. Recent authorisation dates include February-March 2026.
PMDA (Japan): Bevacizumab approved April 2007 and May 2016.
TGA (Australia): Bevacizumab approved with PBS codes 12479T, 12508H, 12508H. Sponsors include Amgen Australia Pty Limited (June 1, 2021), Celltrion Healthcare Australia Pty Ltd (December 1, 2022), and Sandoz Pty Ltd (October 1, 2024).
NMPA (China): Bevacizumab in clinical trials. Multiple NCT IDs indicate ongoing trial activity: NCT01695772, NCT02250599, NCT02759614, NCT03095001, NCT03905317, NCT05111860, NCT05314101, NCT05445778, NCT05503667, NCT05797467.
Combination Program Status: Regulatory pathway and approval status for the bevacizumab/irinotecan combination not yet disclosed.
Bevacizumab/irinotecan is a combination therapy in development for glioblastoma, an aggressive primary brain cancer. The Phase 2 trial was completed in December 2013, but the combination has not yet received regulatory approval.
No. The combination program remains in development status following Phase 2 completion in 2013. Bevacizumab itself is approved globally, but the specific combination therapy regulatory status has not been disclosed.
Bevacizumab is a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), blocking tumor angiogenesis and reducing blood supply to cancer cells.
Irinotecan is a topoisomerase I inhibitor that causes DNA damage and triggers apoptosis (programmed cell death) in cancer cells.
Solid Biosciences is the sponsor of the bevacizumab/irinotecan program (internal code CRCST-L-0006). No development partner is listed in available records.
The program is in completed Phase 2 status as of December 4, 2013. No subsequent development milestones or regulatory actions have been disclosed.
Yes. Bevacizumab is FDA-approved under BLA125085 for multiple oncology indications, though the specific combination with irinotecan for glioblastoma has not been approved.
Yes. Bevacizumab is approved by the EMA with 16 marketing authorization holders including Amgen Europe B.V., Roche, Pfizer, and multiple biosimilar manufacturers.
Yes. Bevacizumab received PMDA approval in April 2007 and again in May 2016.
Yes. Bevacizumab is approved by the TGA with PBS codes 12479T and 12508H, with multiple sponsors including Amgen Australia, Celltrion Healthcare Australia, and Sandoz.
The Phase 2 trial NCT00921167 evaluated bevacizumab and irinotecan in glioblastoma and was completed December 4, 2013. Detailed results have not been disclosed in available records.
Bevacizumab is administered intravenously. The irinotecan route of administration is not specified in available facts but is typically intravenous.
Bevacizumab/irinotecan is classified as antineoplastic and immunomodulating agents (ATC L01). Bevacizumab is a monoclonal antibody; irinotecan is a small-molecule topoisomerase inhibitor.
Glioblastoma is the most aggressive primary brain cancer with median survival ~15 months despite standard therapy. It is difficult to treat due to rapid growth, angiogenesis, and limited drug penetration across the blood-brain barrier.
Yes. Multiple bevacizumab biosimilars are approved by the EMA, including products from Celltrion, Samsung Bioepis, Mabxience, and others, which may impact pricing and market competition.
Current standard-of-care (temozolomide and radiation) provides limited survival benefit with most patients developing recurrent disease. New therapeutic options with improved efficacy are critically needed.
Publication status of the Phase 2 trial (NCT00921167) results is not disclosed in available facts. Trial completion was reported December 4, 2013, but detailed efficacy and safety data have not been made publicly available in these records.
Bevacizumab/Irinotecan → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: Solid Biosciences' development of this combination reflects rational drug design targeting glioblastoma's dual pathology of angiogenesis and tumor cell proliferation. The Phase 2 completion in 2013 without subsequent disclosed milestones suggests either: (1) transition to Phase 3 evaluation not yet publicly announced, (2) commercial licensing discussions, or (3) program deprioritization. The lack of recent activity over a decade warrants clarification.
Competitive Implications: Bevacizumab's established safety profile and global approvals provide a de-risked backbone for combination approaches. However, biosimilar proliferation (15+ EMA-approved biosimilars) may compress pricing and reduce combination therapy margins. The competitive set for glioblastoma is evolving with checkpoint inhibitors and novel targeted agents in development; this combination's position depends on Phase 2 efficacy data and comparative outcomes.
Future Catalysts: Publication of Phase 2 trial results would be critical to assess clinical benefit and inform next-stage development decisions. Regulatory feedback from FDA or EMA regarding combination approval pathway would clarify commercial viability. Partnership announcements or licensing deals could accelerate development if data support advancement.
Expected Milestones: No milestones are currently disclosed. Potential future catalysts include Phase 2 data publication, Phase 3 initiation (if warranted), regulatory interactions, or partnership announcements.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.