Brentuximab Biosimilar: Advancing CD30-Targeted Therapy

Brentuximab vedotin is a CD30-targeting antibody-drug conjugate (ADC) approved for treating CD30-positive malignancies, such as Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). This ADC combines a monoclonal antibody targeting CD30 with a cytotoxic payload, monomethyl auristatin E (MMAE), to selectively kill cancer cells. The biosimilar HDBS0017 offers the same clinical efficacy and safety as the original biologic at a reduced cost, increasing access to this life-saving therapy.

CD30 in Malignancies

CD30 is a cell surface protein expressed on:

• Reed-Sternberg cells in classical Hodgkin lymphoma (HL).
• Activated T and B cells in ALCL.
• Other CD30-positive malignancies, such as cutaneous T-cell lymphoma (CTCL).

CD30 is minimally expressed in normal cells, making it an ideal target for antibody-drug conjugate therapy.

Features of HDBS0017

HDBS0017 is a biosimilar to Brentuximab vedotin, providing equivalent safety, efficacy, and quality at a more affordable price.

• Target: CD30-positive malignant cells.
• Mechanism: Delivers MMAE to selectively kill tumor cells.
• Affordability: Reduces costs, improving global access to ADC therapy.

HDBS0017 is primarily indicated for the treatment of CD30-positive malignancies.

Hodgkin Lymphoma (HL)

Frontline Therapy

• HDBS0017 is used in combination with chemotherapy (e.g., AVD: doxorubicin, vinblastine, dacarbazine) for untreated HL.
• Improves progression-free survival compared to standard chemotherapy alone.

Relapsed or Refractory HL

• As monotherapy or part of salvage regimens, HDBS0017 is effective in relapsed/refractory cases following stem cell transplant or chemotherapy.

Anaplastic Large Cell Lymphoma (ALCL)

• Effective in both systemic and cutaneous forms of ALCL, achieving high response rates.

Other CD30-Positive Malignancies

• Cutaneous T-Cell Lymphoma (CTCL): Approved for CD30-expressing variants such as mycosis
  fungoides.
• Peripheral T-Cell Lymphoma (PTCL): Under investigation as part of combination regimens.

Targeted Tumor Destruction

HDBS0017 delivers its cytotoxic payload directly to CD30-positive cells, sparing healthy tissue and reducing systemic toxicity.

Cost-Effective Treatment

By lowering costs, HDBS0017 expands access to CD30-targeted therapies, particularly in low-resource settings.

Versatile Applications

Effective as monotherapy and in combination regimens, HDBS0017 is adaptable to various CD30-positive cancers and treatment settings.

Adverse Effects

• Peripheral Neuropathy: A common side effect due to MMAE, requiring dose modifications.
• Hematologic Toxicity: Includes neutropenia and thrombocytopenia, manageable with supportive care.

Resistance Development

• Downregulation of CD30 expression or increased drug efflux may lead to resistance. Combination therapies can mitigate this risk.

Expanded Indications

HDBS0017 is under investigation for use in additional CD30-positive malignancies and combination regimens:

• Diffuse Large B-Cell Lymphoma (DLBCL): Investigating its potential in CD30-positive subtypes.
• Pediatric Cancers: Exploring use in CD30-positive pediatric Hodgkin lymphoma and other rare malignancies.

Novel Combinations

• Checkpoint Inhibitors: Combining HDBS0017 with PD-1/PD-L1 inhibitors may enhance anti-tumor immune responses.
• Chemotherapy and Targeted Agents: Synergistic effects observed with agents like pralatrexate or romidepsin in T-cell lymphomas.

The Brentuximab biosimilar HDBS0017 offers a transformative approach to treating CD30-positive malignancies. By combining targeted therapy with a potent cytotoxic payload, HDBS0017 provides effective and durable responses in Hodgkin lymphoma and related cancers. As a cost-effective alternative, HDBS0017 expands access to cutting-edge therapy, improving outcomes for patients worldwide. 

1. Younes, A., et al., 2018. Brentuximab vedotin in combination with chemotherapy for Hodgkin's lymphoma. NEJM, 378(4), pp.331-344.
2. Pro, B., et al., 2012. Brentuximab vedotin for relapsed ALCL: Efficacy and safety. Journal of Clinical Oncology, 30(18), pp.2190-2196.
3. ClinicalTrials.gov, 2023. Studies on Brentuximab vedotin and biosimilar HDBS0017. Available at www.clinicaltrials.gov.
4. European Medicines Agency (EMA), 2023. Guidelines on biosimilar development for ADCs. Available at www.ema.europa.eu.
5. Horwitz, S.M., et al., 2018. Targeting CD30 in T-cell lymphomas: Brentuximab vedotin and beyond. Blood Advances, 2(15), pp.1665-1673.