How will fate fare for Roche’s two anticancer drugs?

Polivy and Tecentriq, Roche’s two anticancer drugs that failed a series of reimbursement attempts at the CDDC stage, pass review and receive reimb standards at the third attempt

Company to add research data… attention rises on whether it will be reviewed by DREC in the second half of the year

The industry’s eyes are on whether Roche's two anti-cancer drugs, which have faced repeated failures, will succeed in securing reimbursement listing this time.

 

According to industry sources, Roche Korea's treatment for refractory diffuse large B-cell lymphoma(DLBCL), ‘Polivy (polatuzumab vedotin)’ and the PD-L1 inhibitor-based immunotherapy ‘Tecentriq (atezolizumab)’ passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee last month and are currently under discussion for submission to the Drug Reimbursement Evaluation Committee.

 

Both drugs failed to clear the Cancer Disease Deliberation Committee hurdle twice before finally passing on their third attempt.

 

Therefore, it remains to be seen whether Roche, a pharmaceutical company specializing in anticancer drugs that has particularly struggled with Cancer Disease Deliberation Committee approvals since last year, can now achieve progress simultaneously in solid tumors and hematologic malignancies.

 

Polivy originally aimed for reimbursement in 2021 for its first indication - third-line therapy in combination with BR therapy (bendamustine and rituximab), but failed to clear the CDDC hurdle.

 

In the first half of 2023, Roche submitted a reimbursement application for Polivy’s use as first-line therapy in combination with R-CHP therapy (rituximab + cyclophosphamide, doxorubicin, prednisone).

 

However, this application also faced rejection by the CDDC in February of last year.

 

However, there is still hope.

 

Polivy added the 60.9-month follow-up analysis results from the POLARIX study, which evaluated the efficacy of the Pola-R-CHP combination therapy as first-line treatment for DLBCL last year.

 

In the case of Tecentriq, the drug’s reimbursement was first submitted to the Health Insurance Review and Assessment Service (HIRA) for review in May 2023, but it failed to set the reimbursement criteria.

 

Its second attempt was again rejected by HIRA in July last year.

 

At that time, Roche failed to secure reimbursement standards despite presenting additional results showing improved overall survival (OS) at the American Society of Clinical Oncology (ASCO) meeting.

 

Meanwhile, the Polarix follow-up study of Polivy, presented at the American Society of Hematology (ASH) Annual Meeting 2024, is considered the first clinical trial in 20 years to expand the standard first-line treatment for DLBCL.

 

Key results show that the Polivy combination therapy group demonstrated a clear improvement in overall survival (OS) compared to the control group treated with the existing standard therapy, R-CHOP.

 

The lymphoma-related mortality rate was 9.0% in the Polivy combination therapy group and 11.4% in the R-CHOP control group.

 

Approximately 5 years after treatment initiation, the risk of death in the Polivy combination therapy group decreased by 15%, an improvement over the previous 3-year follow-up result (6% risk reduction).

 

In the case of Tecentriq, the 5-year follow-up study of IMpower010 showed that in patients with stage 2-3A non-small cell lung cancer (NSCLC) with PD-L1 expression ≥50%, who underwent complete resection and platinum-based chemotherapy, the Tecentriq adjuvant therapy arm resulted in an OS of 82.7%, which was significantly higher than that of the best supportive care (BSC) arm (65.3%).