First-line treatment of advanced kidney cancer! Pfizer/Merck Immunity and Targeting Group Bavencio and Inlyta performed strongly

. pharmaceutical giant Pfizer and partner Merck KGaA recently jointly announced the evaluation of PD-L1 oncology immunotherapy Bavencio (avelumab) in combination with tyrosine kinase inhibitor Inlyta (avelumab) The interim analysis data for JAVENLIN Renal 101, a key Phase III clinical study for patients with advanced renal cell carcinoma (RCC), was published online in the International Journal of Medicine (NEJM). The results showed that the Bavencio-Inlyta combination showed significant efficacy compared to Suttent (Sotan, universal name: sunitinib, Shonithini), and showed significant results in the group of patients with good prognosis, medium and poor prognosis.
last week, the FDA accepted the Bavencio-Inlyta First-Line Treatment Late RCC Supplemental Biologics License (sBLA) and granted priority review eligibility. The FDA has designated the SBLA's Prescription Drug User Charge Act (PDUFA) target date as June 2019. Previously, in December 2017, the FDA granted Bavencio-Inlyta a breakthrough drug for first-line treatment of advanced RCC. Although treatments are available, the prognosis for patients with advanced RCC is still poor. It is estimated that approximately 20 to 30 per cent of patients are already in the transfer phase at the time of the first diagnosis, and the five-year survival rate for patients with transfer RCC is approximately 12 per cent.
JAVELIN Renal 101 is a global, multi-center, randomized Phase III study conducted in 886 patients with late-stage RCC, evaluating the efficacy and safety of Bavencio's combined Inlyta for first-line treatment relative to Suttent, a standard care drug developed by Pfizer and the first-line treatment of RCC over the past 10 years. The main purpose of the study was to prove that the Bavencio-Inlyta combination therapy was superior to Sutt in prolonging progressed non-progressed survival (PFS) or total lifetime (OS) in patients with PD-L1-positive advanced RCC.
results showed that (1) in patients who were positive for PD-L1 (expression level ≥1%) significantly reduced the risk of disease progression or death by 39% (medium PFS: 13.8 months vs 7.2 months; HR s 0.61 (95% CI: 0.475-0.790), p<0.0001), ORR doubled significantly (55.2% vs 25.5%) ;(2) significantly reduced the risk of disease progression or death by 31% across the study group (medium PFS: 13.8 months vs 8.4 months; HR =0.69) 95% CI: 0.563-0.840, p<0.0001), ORR significantly doubled (51.4% vs 25.7%). The study continues to track total lifetime (OS) endpoint data.
Recently, at the 2019 American Society of Clinical Oncology's Urology (ASCO-GU), Merck and Pfizer released additional data that enhanced the consistency of PFS and ORR results in the patient subset, including patients with low risk (good prognosis), medium risk (mid-prognosis), high risk (prognosis), and patients with positive or negative tumor PD-L1. In the subgroup analysis, two-thirds of low-risk patients received a combination of Bavencio and Inlyta to achieve complete or partial remission, and the mid-PFS in these patients was not yet estimated. In addition, the Bavencio-Inlyta combination extended the progression or death of the second disease (medium PFS2:NE vs 18.4 months; HR=0.56 (95%CI:0.42-0.74) and the duration of the remission increased by 4 months (95% CI:2.9-5.1).
The consistency of PFS and ORR observed so far in all patients, including subgroups, suggests that many different types of patients, including those with good prognosis, moderate prognosis, and poor prognosis, may benefit from this combination of immunity and targeting," said Robert J. Motzer, lead researcher on the
JAVELIN Renal 101 study and chairman of clinical oncology at Memorial Sloan Kettering Cancer Center. The Bavencio-Inlyta combined treatment may become an important, new, first-line treatment for patients with advanced RCC. The
JAVELIN Renal 101 study is part of the JAVELIN Clinical Development Program, which involves at least 30 clinical projects, more than 15 different types of tumors, and more than 9,000 patients. In addition to ovarian cancer, these tumor types include breast cancer, stomach cancer/gastroesophageal junction and head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, renal cell carcinoma and urethra skin cancer.
Pfizer signed a $2.85 billion deal with Merck in November 2014 to enter the PD-(L)1 field. 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, by blocking the PD-1/PD-L1 signaling path pathrapies to kill cancer cells, with the potential to treat a variety of types of tumors. Developed by Pfizer, Inlyta is an oral therapy designed to inhibit tyrosine kinases, including vascular endotrative growth factor (VEGF) subjects 1, 2 and 3, which may promote tumor growth, angiogenesty, and cancer progression (tumor spread). (Bio Valley)