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

14, 2020 // -- Merck KGaA and partner Pfizer have jointly announced that the European Commission (EC) has released a A positive review recommended approval of the anti-PD-L1 therapy Bavencio (avelumab) as a single-drug therapy for first-line maintenance therapy in adult patients with localized advanced or metastatic urethratic skin cancer (UC) who did not progress after receiving first-line platinum-containing chemotherapy.
, CHMP's comments will now be submitted to the European Commission, which is expected to make a final review decision in early 2021.
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, 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 from first-line platinum-containing chemotherapy.
, Bavencio's symptoms are also under regulatory scrutiny in Japan and other countries.
particular note, Bavencio is the only immunotherapy that significantly prolongs the total survival (OS) of localized late-stage or metastasis UC patients in phase III clinical trials of first-line therapy.
fda's full approval and positive review by CHMP in the European Union are based on positive results from the JAVALIN Bladder 100 study, which was published in the New England Journal of Medicine (NEJM) in September.
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 improved one-year survival compared to Best Support Care (BSC).
clinical benefits of Bavencio are reflected in a range of patient groups.
Chris Boshoff, M.D., Chief Development Officer, Global Product Development, Pfizer, said: "In Europe, patients with localized advanced or metastatic urethra skin cancer urgently need more treatments that have the potential to extend their life.
results from the JAVELIN Bladder 100 study showed that the use of Bavencio's first-line maintenance therapy was a significant advance for patients with localized advanced or metastatic urethra cancer.
, if approved, has the potential to change the treatment patterns of patients in Europe.
" 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, evaluated 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 survival (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 showed that at the time of the interim analysis, the study had reached the primary endpoint 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).
- In all randomized patients (n-700), the mid-OS in the Bavencio-BSC group was significantly longer (21.4 months vs 14.3 months) and the risk of death was reduced by 31% (HR-0.6) compared to the BSC group 9;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.
- 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-0.56) compared to BSC 95% CI: 0.40-0.79; p<0.001), 12-month survival rate increased significantly (79.1% vs 60.4%).
- The results of the exploratory subgroup analysis showed that the first-line maintenance therapy of the Bavencio-BSC programme observed consistent results in all pre-designated subgroups, including the optimal response to first-line chemotherapy, the type of chemotherapy programme, baseline transfer sites and other baseline factors.
In particular: (1) according to the response to first-line chemotherapy, the risk ratio of OS (HR) is: HR in complete or partial remission, HR in patients with stable disease is 0.70;
study, Bavencio's safety was consistent with JAVELIN's single-drug clinical development program.
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 has the potential to change 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 Tumor Immunotherapy, a high-profile type of tumor immunotherapy designed to use the body's own immune system to fight cancer and kill cancer cells by blocking the PD-1/PD-L1 signaling path, with the potential to treat multiple types of tumors.
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.
() Origin: BAVENCIO? (AVELUMAB) RECEIVES POSITIVE CHMP OPINION FOR FIRST-LINE MAINTENANCE TREATMENT OF LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA。