"Effect of Bavencio on long-term survival confirmed"

"Bavencio is currently recommended as a standard-of-care"

Consistent effectiveness have been confirmed in global RWD, including the U.S., Europe, Japan, and Korea

Overall survival surpassing 40 months have been recorded…the efficacy was proven in analysis in Korea

Professor Jae-lyun Lee of Seoul Asan Hospital

At the conference held in Korea, Bavencio's real-world data (RWD) have been unveiled, extending beyond its initial trial that served as the basis for approval.

 

Bavencio maintenance therapy has been shown to prolong the lives of patients with urothelial carcinoma in multiple countries, including Korea, Japan, France, and the U.S.

 

Notably, the sequential treatment results with an antibody-drug conjugate (ADC), a global R&D trend, have also been positive.

 

Global RWD Shows OS Surpassing 40 Months...ADC Combination Strategy Yielded Results At the annual meeting of the Korean Society of Medical Oncology (KSMO) held on September 5, long-term survival outcomes for Bavencio (avelumab), a treatment for advanced or metastatic urothelial carcinoma, were unveiled.

 

The key result was that the latest result from a real-world clinical setting surpassed the overall survival (OS) observed in Bavencio's approval trial, JAVELIN Bladder 100 (JB 100) trial.

 

The platinum-based chemotherapy previously used for patients with metastatic urothelial carcinoma shows high response rates.

 

However, its toxicity and lack of durability made long-term treatment difficult, with survival benefits lasting only 12-15 months.

 

Even with a response, 70% of patients relapsed within a year, patients and doctors having to endure treatment gaps.

 

Bavencio recorded a median OS of 29.7 months in the JB 100 trial, an improvement of over 9 months.

 

This effect was consistently confirmed in global RWD involving over 5,100 patients from the U.S., Europe, Japan, and Korea, with some cohorts even reporting superior results.

 

The value of an anti-cancer drug depends on whether its clinical trial outcomes can be reproduced in a real-world setting.

 

While clinical trials are conducted under limited conditions, real patient populations are far more complex.

 

RWD is considered a key piece of evidence that bridges this gap and validates the efficacy and safety of a treatment.

 

Professor In-Ho Kim of Seoul St.

 

Mary's Hospital's Division of Medical Oncology, who presented on the changes in metastatic urothelial carcinoma (mUC) treatment in Korea and the significance of first-line maintenance therapy, stated Bavencio's outstanding tolerability as a key strength.

 

The advantage of this drug enables patients to continue treatment stably for an extended period.

 

Professor In-Ho Kim of Seoul St.

 

Mary

Professor Kim explained, "The results confirmed in Bavencio's clinical trials are being directly replicated in real-world clinical setting.

 

Specifically, it has been demonstrated that toxicity issues, which were effectively managed under strict monitoring in clinical trials, can also be adequately controlled in a real-world setting.

 

Thanks to these characteristics, We believe Bavencio is not just a new treatment option for patients but is setting a criteria for long-term treatment." For example, the PATRIOT-II study in the U.S., which analyzed the medical records of 160 patients, showed a median OS of 30.5 months from the start of chemotherapy and 24.4 months from the beginning of maintenance therapy.

 

The JAVEMACS study conducted in Japan showed that the long-term survival effect was also replicated in an Asian patient population, with a median OS of 38.9 months from the start of chemotherapy and 31.8 months from the beginning of maintenance therapy.

 

The AVENANCE study conducted in France is also notable.

 

In a subgroup of 55 patients who received Bavencio maintenance therapy after first-line chemotherapy and then received the ADC enfortumab vedotin as a second-line therapy, the median OS reached 41.5 months.

 

This contrasts with the median OS of just 24.5 months in a group of patients with similar conditions who received a platinum-based chemotherapy again.

 

Such results demonstrate that the possibility of treatment sequence of 'platinum chemotherapy-Bavencio-ADC' as a long-term survival regimen.

 

Furthermore, it is significant that the study included over 15% of patients with a performance status of ECOG 2 or higher, proving its efficacy even in a more realistic patient population.

 

Korea data have also supported these results.

 

An analysis of an Expanded Access Program (EAP) involving 30 patients from five Korean hospitals between 2021 and 2023 showed that the median progression-free survival (PFS) from the start of Bavencio was 7.9 months, surpassing the 5.5 months in the JB 100 trial.

 

The complete response (CR) rate was 20%, with a median duration of CR of 17.8 months.

 

The fact that these results were consistent with global outcomes, despite a challenging patient population where 67% were Stage 4 at diagnosis and 40% had visceral metastases, is significant.

 

This is also the reason why Bavencio quickly became the standard of care for first-line maintenance therapy soon after its approval for reimbursement.

 

Professor Jae-lyun Lee of Seoul Asan Hospital's Department of Oncology, who chaired the session, emphasized, "Bavencio is a treatment that fundamentally overturned the previous 12-15 month survival median with a median OS of 29.7 months." Lee added, "The fact that the survival benefit confirmed in the clinical trials has been replicated in RWD shows that long-term survival is no longer just an expectation but a reality." Bavencio is also supported by evidence of effortless side effect management and improved quality of life.

 

In both clinical trials and RWD, adverse reactions were mild or manageable, and treatment discontinuation was rare.

 

Long-term administration was possible even in elderly patients and those with comorbidities, and it yielded positive results in terms of quality of life indicators.

 

A post-hoc analysis using the Q-TWiST index showed that Bavencio-treated patients had, on average, 4.2 months longer time without toxicity than those in a standard-of-care group.

 

Based on this various clinical trial and RWD evidence, Bavencio is currently recommended as a standard-of-care for first-line maintenance therapy in metastatic urothelial carcinoma by organizations including the National Comprehensive Cancer Network (NCCN), the European Society for Medical Oncology (ESMO), and the European Association of Urology (EAU).

 

In particular, it is designated as a Category 1 treatment in the NCCN guidelines.

 

In Korea, patient access has also significantly improved following Bavencio approval in 2021 and reimbursement in August 2023.

 

Professor Hongsik Kim of Chungbuk National University Hospital

Professor Hongsik Kim of Chungbuk National University Hospital's Department of Hematology and Oncology, who presented on the topic of 'The Treatment Journey for Metastatic Urothelial Carcinoma,' said, "Bavencio can be safely administered to elderly patients and those with chronic kidney disease.

 

The fact that this drug can provide long-term and sustained responses makes it clinically very significant.

 

Although immune-related adverse events (irAEs) may occur during immunotherapy, it is important to maintain careful clinical judgment and not prematurely discontinue treatment." Professor Kim added, "irAEs can occur even more than a year after treatment, making careful long-term monitoring essential.

 

Considering all these factors, We believe Bavencio is an option that can reliably provide patients with long-term treatment opportunities in a real-world clinical setting." Finally, Professor Lee added, "While various options are emerging in the urothelial carcinoma treatment market, it is rare to find a drug like Bavencio with proven long-term follow-up data and broad RWD." Lee concluded, "With the clinical efficacy, safety, and health insurance reimbursement of Bavencio, it has become a standard-of-care in Korea."