Bladder cancer is heavy! EU approves Merck/Pfizer immunotherapy Bavencio for first-line maintenance therapy: will change clinical practice!

January 26, 2021 // -- Merck KGaA and partner Pfizer recently jointly announced that the European Commission (EC) Anti-PD-L1 therapy Bavencio (avelumab) has been approved as a single-drug therapy for first-line maintenance therapy in adult patients with localized advanced or metastatic urethratic skin cancer (UC) who have no progression after first-line platinum-containing chemotherapy.
particular note that Bavencio is the only immunotherapy that significantly prolongs the total survival (OS) of locally advanced or metastasis UC patients in phase III clinical trials of first-line therapy.
this approval has the potential to change treatment patterns and provide these patients with a new standard of maintenance care to help prolong their lives.
Bavencio, an immuno-oncology drug developed in collaboration with Pfizer and Merck, was approved by the FDA in May 2017 to treat patients with localized advanced or metastatic urethroid skin cancer (mUC), specifically: (1) patients with progression during or after platinum chemotherapy;
June 2020, based on the results of a validated Phase 3 JAVELIN Bladder 100 study, the FDA approved the conversion of Bavencio's treatment of UC adaptation from accelerated approval to full approval: maintenance therapy for patients with local late stage or metastasis UC who did not progress with first-line platinum-containing chemotherapy.
, Bavencio's symptoms are also under regulatory scrutiny in Japan and other countries.
fda's full approval and EU approval are based on positive results from the JAVALIN Bladder 100 study, which was published in the New England Journal of Medicine (NEJM) in September 2020.
data show that in all two major groups of randomly grouped patients and tumor PD-L1-positive patients, bavencio-BSC first-line maintenance therapy significantly extended total survival (OS) and significantly increased one-year survival rates compared to Best Support Care (BSC).
clinical benefits of Bavencio are reflected in a range of patient groups.
based on these data, Bavencio's first-line maintenance program has been added to the recently updated ESMO Clinical Practice Guidelines for EsMO Bladder Cancer.
Bladder Cancer (Photo Source - medscape.com) JAVELIN Bladder 100 (NCT02603432) is a multi-center, multi-country, random, open label The parallel group study, conducted in patients with local late stage or metastasis UC who did not progress after the completion of first-line platinum-containing chemotherapy, assessed the efficacy and safety of Bavencio Combined Best Support Care (BSC) and single-use BSC for first-line maintenance therapy.
study, a total of 700 patients who had no progression after induction chemotherapy (evaluated according to RECIST v1.1) were randomly assigned to the Bavencio-BSC treatment group or the BSC treatment group.
endpoints are total lifetime (OS) in all randomized patients and patients with PD-L1-positive tumors.
the study, BSC will be performed at the discretion of the therapist and may include antibiotic therapy, nutritional support, metabolic disorder correction, optimal symptom control and pain management (including palliative radiation).
BSC does not include any active anti-tumor therapy, but dividend local radiation therapy for isolated lesions is acceptable.
results show that in the medium-term analysis, the study reached the main end point of OS: Bavencio-BSC resulted in a statistically significant improvement in OS compared to BSC in two common major groups (all randomized patients, PD-L1-positive tumor patients): (1) in all randomized patients (n-700), compared to the BSC group, Bavencio-BSC group had significantly longer OS (1) 21.4 months vs 14.3 months), 31% reduction in risk of death (HR s 0.69; 95% CI: 0.56-0.86; p<0.001), 12 month survival rate (71% vs 58%) and 18 month survival rate (61% vs 44%) increased significantly.
(2) In patients with PD-L1-positive tumors (n-358), Bavencio-BSC showed greater OS benefits and reduced the risk of death by up to 44% (HR-0.2) compared to BSC 56;95%CI:0.40-0.79;p<0.001), 12-month survival rate increased significantly (79.1% vs 60.4%).
latest OS results as of January 19, 2020 also showed that Bavencio-BSC significantly extended OS (mid-OS: 22.1 months vs 14.6 months; HR=0.70, p=0.0008) compared to BSC in all randomized patients.
the study, Bavencio was the first immunotherapy to achieve a statistically significant improvement in OS in clinical trials with a first-line treatment of late-stage UC.
chemotherapy has been the standard of care for patients with advanced urethra skin cancer for the past 30 years.
is an effective short-term option for many patients, most patients will eventually experience disease progress, underscoring the need for more treatment options.
based on positive total lifetime (OS) results from the JAVENLIN Bladder 100 study, Bavencio changed clinical practice.
bladder cancer is the 10th most common cancer worldwide.
2018, more than half a million new cases of bladder cancer have been confirmed, and about 200,000 people worldwide will die from bladder cancer.
UC accounts for about 90 per cent of bladder cancer.
for patients with advanced UC, the five-year survival rate was only 5%.
estimates that about 4% of bladder cancer patients are in their late stages of diagnosis.
Currently, platinum-containing chemotherapy is the first-line standard for treating late-stage UC, and although the initial remission rate is high, continuous remission and complete remission after first-line chemotherapy is not common, with most patients eventually developing the disease within nine months of starting treatment.
considering the poor progression of late-stage UC patients after first-line chemotherapy, additional treatment options are urgently needed to extend life expectancy.
Bavencio belongs to PD-(L)1 oncology immunotherapy, a high-profile type of tumor immunotherapy designed to use the body's own immune system to fight cancer and have the potential to treat multiple types of tumors by blocking the PD-1/PD-L1 signaling path.
Bavencio has been shown in preclinical models to be able to participate in both adaptive and congenital immune functions.
Bavencio has been shown to release inhibition of T-cell-mediated anti-tumor immune responses in preclinical models by blocking the interaction between PD-L1 and PD-1 receptors.
Pfizer signed a $2.85 billion deal with Merck in November 2014 to enter the PD-(L)1 field.
, the two sides are currently advancing the JAVELIN Clinical Development Program, which involves more than 15 different types of tumors and more than 10,000 patients.
In addition to stomach/gastroesophageal junction adenocarcinoma, these types of tumors include: ovarian cancer, breast cancer, head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, renal cell carcinoma and urethra cancer.
() Original source: European Commission approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma<!--/ewebeditor:page->