Roche spotlights Polivy, Columvi as new standards reshape Korea’s DLBCL treatment landscape

Roche Korea outlined its expanding lymphoma portfolio during a media session at its headquarters in Seoul on Tuesday, presenting  evidence for Polivy (polatuzumab vedotin) and Columvi (glofitamab) as global guidelines increasingly position both therapies at the center of diffuse large B cell lymphoma (DLBCL) treatment.

DLBCL is the most common form of lymphoma and one of the most aggressive. About 40 percent of patients relapse or become refractory after first line R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) treament with outcomes worsening rapidly once treatment fails.

Conventional chemotherapy and autologous stem cell transplantation continue to play a role but often cannot be applied to older adults or patients with comorbidities because of high toxicity.

“Among the many types of blood cancers, lymphoma is the most frequent, and within lymphoma, DLBCL is the most common,” said Professor Kim Seok-jin, Chairman of the Korean Society of Hematology (KSH) and Professor of Hematology-Oncology at Samsung Medical Center. “This is not only Korea’s problem but a global issue. When a disease is this common among conditions that require treatment, it means it is one of the illnesses that troubles our people the most.”

Kim stressed that early treatment remains the most decisive factor in long term outcomes.

“As with any cancer, completing treatment at the first line gives the best prognosis,” he said. “Once treatment moves to the second or third line, the chance of cure goes down and the cost goes up.”

That cost includes not only the expense of therapy but also the broader social cost, he added.

Roche’s ADC Polivy, the first CD79B-targeted antibody drug conjugate for DLBCL, has become the first new first line standard in about 20 years when used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone as the R-CHP regimen. It is now the only Category 1 recommendation for previously untreated DLBCL across all stages in the U.S. NCCN guidelines.

Five year follow up results from the global phase 3 POLARIX study showed that Polivy plus R-CHP reduced the risk of disease progression, relapse or death by 22 percent.

The five year progression free survival rate improved from 59.1 percent to 64.2 percent, and overall survival rose from 79.6 percent to 82.2 percent. The regimen also decreased the expected number of patients needing subsequent therapies over the next 10 years by 23 percent.

“For patients preparing to enter a clinical trial, the waiting period is difficult,” Kim said. “The POLARIX study being the first in this setting to meet its endpoint is very meaningful as Polivy R-CHP not only improves outcomes but also reduces the number of patients who will require further treatment in the next 10 years.”

That offers clinical as well as socioeconomic benefit, he added.

During the session, Kim also described a recent real world case illustrating the impact of reimbursement delays.

“Today I saw a stage 4 DLBCL patient for whom Polivy seemed appropriate,” the KSH Chairman said. “But it is still non-reimbursed, and the cost is extremely high.”

Waiting until reimbursement is finalized would be risky and the patient asked for one day to think about whether he would have to sell his house for the treatment, this is the reality in Korea, he added.

Columvi, Roche’s CD20xCD3 bispecific antibody, also featured prominently as a rapidly acting off-the-shelf option for relapsed or refractory patients.

Its two-to-one structure binds two CD20 epitopes on malignant B cells and one CD3 epitope on T cells, enhancing immune synapse formation. Global guidelines including NCCN, EHA and ESMO list Columvi as a category one option after at least one prior systemic therapy.

Two year results from the STARGLO phase 3 trial showed that Columvi plus gemcitabine and oxaliplatin reduced the risk of death by 41 percent compared with rituximab/ gemcitabine/oxaliplatin (GemOX).

The complete response rate reached 58.5 percent, more than double the comparator. More than 80 percent of patients who achieved complete response remained alive and progression free one year after completing the 12-cycle fixed treatment course.

“Achieving remission is possible, but maintaining it is difficult,” Kim said. “More than 80 percent of patients who reached complete remission in the Columvi arm were still alive without disease progression one year after finishing treatment and that is a meaningful outcome.”

Kim added that bispecific antibodies and CAR-T therapies should be seen as complementary.

“For patients who can tolerate side effects, CAR-T is chosen and for those who cannot, we choose a bispecific,” he said. “If all new drugs were reimbursed, we would prescribe according to global guidelines.”

The problem is that even when effective treatments exist, approval and reimbursement barriers force us to repeat the same therapies, he added.

Regarding Kim’s concerns, Roche Korea explained it is working to accelerate reimbursement for the two drugs.

Polivy passed cancer drug review in July and is undergoing HIRA evaluation. Columvi was resubmitted for second and third line reimbursement after an earlier review did not advance.