Roche obtains special authorisation for bispecific antibody
Roche obtained from European Medicine Agency (EMA) a special authorization (conditional approval) for new bispecific antibody Lunsumio for treatment of relapsed or refractory follicular (R/R) lymphoma (FL) - a B-cell cancer. Data for authorization are based on a survey from a phase I/II trail. The high unmet need of this indication led to that early decision, it is said.
Roches new developed immunotherapy is based on a bispecific antibody, which targets B-lymphocyte antigen CD20 and the CD3-T-cell receptor at the surface of T-cells. Lunsumio is applied to adult patients with relapsed or refractory follicular lymphoma (FL), which received at least two other cancer therapies before.
According to information of the company, Lunsumio (mosunetuzumab) is uncomplicated to apply and used without chemotherapeutic drugs. Patients can start at any time with therapy. In the phase I/II trail a very good efficacy could be demonstrated, which last until 18 month. In that interventional, open-labeled and multicentre GO29781 trail 836 participants were administered intravenous or subcutaneous with mosunetuzumab allone or in combination with another drug, atezolizumab, used for treatment of the Non-Hodgkin-Lymphom. The trail served to review the safety, efficacy and pharmacokinetics of Lunsumio in patients with FL. An independent evaluation came, according to Roche, to a positive result regarding efficacy and tolerability of the new drug. Lunsumio led in patients, which suffered from a severe course of FL in a 80% of shrinking of tumors. In 60% of patients tumors cleared out.
Roches bispecific antibody competes with Novartis CAR-T-Therapy Kymriah (tisagenlecleucel), which target CD19-Lymphocytes and was developed for treating same indication like Lunsumio. Just last month the therapy received a positive reply from European approval authority. Kymriah had an effect in 86% of patients, by 69% completely.
Further developments for treatment of FL are from Gilead Science with it´s CAR-T Yescarta und by Bristol Myers Squibbs Breyanzi. As disadvantages in comparison to (bispecific) antibodies cell therapy comes with complex and lengthy manufacturing process, and patients have to consult a spezialised therapy centre for treatment.
In addition Roche has another bispecific antibody in approval process, called glofitamab. In near future, in a phase III trail called SUNMO, Lunsumio will be tested in combination with Roches chemotherapeutic (ADC) drug Polivy which just got the green light by EMA. Analysts estimate, that both antibodies will reach up to 2 billion US-Dollar.
General information: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc
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