Roche's bispecific blood cancer drug Lunsumio treads on CAR-T's turf with first global approval

After Rituxan’s fall off the patent cliff, Roche is looking to new assets to replenish its blood cancer arsenal. With a first-in-class nod, the Swiss pharma is introducing a novel bispecific lymphoma drug that will first compete with powerful CAR-T therapies.

Roche has won a conditional European Commission approval for Lunsumio, or mosunetuzumab, to treat follicular lymphoma patients who’ve received at least two prior therapies. The go-ahead makes Lunsumio the first CD20xCD3 bispecific antibody approved anywhere. Roche submitted the drug to the FDA in December.

“Lunsumio is an off-the-shelf therapy that is readily available, so people do not have to wait to start treatment,” Roche pointed out Wednesday. That statement seems to be a direct shot at a class of efficacious but less convenient drugs: CAR-T cell therapies.

Before Lunsumio, European regulators last month approved Novartis’ CD19-directed CAR-T therapy Kymriah for the exact same third-line follicular lymphoma (FL) indication. With a positive opinion from the European Medicines Agency, Gilead Sciences’ rival CAR-T drug Yescarta is awaiting a formal expansion into FL after at least three prior lines of therapy.

Also in Europe, Bristol Myers Squibb’s Breyanzi has a third-line nod for an aggressive form of FL known as grade 3B, which is often treated as diffuse large B-cell lymphoma (DLBCL).

But those tailored CAR-T therapies involve complex manufacturing processes that typically take more than two weeks for the final product to be returned to the patient for infusion. And patients currently have to go to designated large treatment centers to get CAR-T treatment.

Now, Roche is touting Lunsumio’s convenience edge. And the drug’s efficacy looks competitive as well.

In the phase 1/2 GO29781 study, Lunsumio shrank tumors in 80% of patients with heavily pretreated FL, including clearing out signs of tumor in 60% of patients. Those results came after a median follow-up of 18.3 months for patients in the trial.

By comparison, Kymriah triggered a response in 86% of patients in the phase 2 Elara trial, including 69% who had a complete response.

“Lunsumio’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a statement.

Besides CD20, which is already targeted by Roche’s off-patent Rituxan, Lunsumio also binds to CD3 on the surface of T cells and redirect the immune cells to help eliminate cancerous B cells.

Roche has another CD20xCD3 bispecific called glofitamab, which has shown some promising results in aggressive DLBCL. Analysts at Jefferies have projected both drugs may reach $2 billion in peak sales.

Lunsumio’s nod comes shortly after Roche snagged an important EU clearance for Polivy in previously untreated DLBCL. Roche is running a phase 3 trial dubbed SUNMO combining Lunsumio with Polivy in second-line DLBCL. It has also said it plans to start a phase 3 trial pairing Polivy with either one of the two CD20xCD3 bispecific antibodies in the first-line setting this year.

It also comes as Roche battles biosims to its older trio of cancer stalwarts. Last year, biosimilars to Rituxan, Herceptin and Avastin eroded 4.5 billion Swiss francs in global sales, the drugmaker said.