Roche accelerates drug reformulation strategy

FDA approves Lunsumio Velo… CD20·CD3-targeting bispecific antibody

Leader in subcutaneous oncology drugs… integrated Halozyme’s technology

Roche is driving a paradigm shift across the oncology field by leading with subcutaneous (SC) formulations.

The company is actively pursuing formulation changes for its new drugs, positioning ease of administration as a core competitive advantage. Its R&D competitiveness has been confirmed through multiple SC formulation development achievements across both solid tumors and hematologic malignancies.

FDA approves Lunsumio Velo…1-minute administration of bispecific antibodies possible

Hematologic cancer therapy Lunsumio

2According to industry sources on the 2nd, Roche recently received approval from the U.S. Food and Drug Administration (FDA) for Lunsumio Velo, the SC formulation of the bispecific antibody Lunsumio (mosunetuzumab). The drug is indicated for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Lunsumio is the first CD20/CD3 T-cell-engaging bispecific antibody approved for relapsed or refractory follicular lymphoma.

The approval was granted under the accelerated approval pathway based on results from the Phase I/II GO29781 study. Full approval will be contingent upon confirmation of clinical benefit in confirmatory trials.

With the approval of Lunsumio Velo, convenience in administration has improved markedly. While the intravenous (IV) formulation requires 2–4 hours of infusion, the SC formulation can be administered in approximately 1 minute. Roche explained that this dramatically reduces the time patients spend in the hospital, enabling treatment tailored to individual clinical needs and preferences.

In the Phase 1/2 GO29781 study, which formed the basis for this FDA approval, Lunsumio Velo demonstrated meaningful anticancer effects even in patients with third-line or later follicular lymphoma, a group with limited treatment options.

Clinical results showed an objective response rate (ORR) of 75% in the Lunsumio Velo treatment group, with 59% achieving complete response (CR). The median duration of response (DOR) among responding patients was 22.4 months.

Safety was considered manageable. The most common adverse events included injection-site reactions, fatigue, rash, cytokine release syndrome (CRS), musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients, with most events being Grade 1–2, typically occurring during Cycle 1 and resolving within a median of two days. Grade 3 CRS was reported in only 2.1% of patients.

Like the IV formulation, Lunsumio Velo can be administered in the outpatient setting and features a fixed-duration treatment approach. Treatment duration may be as short as six months, differentiating it from therapies that require indefinite administration until disease progression.

The IV formulation of Lunsumio has already established itself as the first approved bispecific antibody for third-line or later follicular lymphoma. Roche presented long-term follow-up data for both SC and IV formulations at the American Society of Hematology (ASH) Annual Meeting last year and has submitted these data to regulatory authorities globally, including in Europe. Recently, the European Commission (EC) granted conditional marketing authorization for the Lunsumio SC formulation.

Roche is also conducting studies to move Lunsumio Velo into earlier lines of therapy, including combination with Polivy (polatuzumab vedotin) in second-line or later diffuse large B-cell lymphoma (SUNMO study) and combination with lenalidomide in first-line follicular lymphoma (MorningLyte study).

From Ocrevus to Tecentriq and Phesgo: Roche expands its SC portfolio

Roche has systematically built its SC portfolio by developing and expanding SC formulations for multiple core products.

Recently, the SC formulation of the multiple sclerosis treatment ‘Ocrevus (ocrelizumab)’ also entered the domestic market.

Roche obtained domestic regulatory approval for Ocrevus SC last month. Ocrevus is a humanized monoclonal antibody that selectively targets CD20-expressing B cells and is classified as a high-efficacy therapy that reduces disease activity and delays long-term disability progression in patients with multiple sclerosis.

Compared with the IV formulation, Ocrevus SC reduces administration time to approximately 10 minutes and can be used even in healthcare settings with limited IV infrastructure. The dosing schedule remains unchanged at once every six months, allowing treatment with just two administrations per year—another factor enhancing patient convenience.

Roche’s Phesgo, Ocrevus, and Tecentriq

The shift to SC formulation is also gaining momentum in the solid tumor field. Roche has already secured SC versions of key oncology products, including the immunotherapy Tecentriq (atezolizumab) and the HER2-positive breast cancer therapy Phesgo (pertuzumab/trastuzumab). In particular, Phesgo has been recognized as a successful case where switching from the existing IV combination therapy to a single SC formulation simultaneously improved administration convenience and operational efficiency in clinical practice.

Underpinning this SC transition is Halozyme Therapeutics' ENHANZE drug delivery technology. Roche’s subsidiary Chugai Pharmaceutical secured global rights to use the ENHANZE technology through a partnership with Halozyme in 2022.

ENHANZE is a drug-delivery platform that uses recombinant human hyaluronidase (rHuPH20) to convert IV drugs into SC formulations.

By temporarily injecting hyaluronic acid within subcutaneous tissue, the technology facilitates drug dispersion, enabling high-dose biologics, previously only available via IV, to be administered as a single SC dose. This allows SC administration within 5 minutes compared with IV formulations, significantly reducing treatment burden on patients while greatly enhancing the efficiency of healthcare providers and the entire hospital system.