Professor Yang Yong: Show the dawn of the first-line immunology joint treatment for Reilly Pearl single anti-skin cancer on the urethra.

Urethra skin cancer is a multi-source malignancy that originates from the urethra skin, including renal cancer, ureter cancer, bladder cancer and urethra cancer, and is one of the most common urinary system tumors.
patients with urethra cancer face difficulties such as late diagnosis, easy recurrence and limited treatment.
For patients with locally advanced or metastatic urethroid skin cancer, the standard gisitapon combination cisplatin/carpentrine chemotherapy program can only keep the patient's medium total survival time at 15 months.
In addition, a considerable number of patients are not resistant to chemotherapy, especially metastatic urethra cancer patients are more likely to have renal insexuality, over the past 30 years, local late stage or metastatic urethra skin cancer five-year survival rate of only 5%.
in recent years, immunotherapy, represented by PD-1/PD-L1 inhibitors, has changed the treatment patterns of a variety of advanced malignancies, including urethra cancer.
basic research suggests that urethra skin cancer has strong immunogenicity, positive expression of PD-L1, tumor mutation load (TMB) and mismatch gene repair defects, and is the dominant tumor species of immunotherapy.
from clinical research data, PD-1/PD-L1 inhibitors used in platinum chemotherapy failure of local late stage or metastatic urethra cancer is accurate, has become the preferred treatment for this part of the patient.
In particular, in April this year, the PD-1 inhibitor developed by the domestic innovative company Baiji Shenzhou was approved by the State Drug Administration for the failure of highly expressive platinum-containing chemotherapy for PD-L1 (The treatment of local late stage or metastatic urethra cancer, which includes progress within 12 months of new assisted or assisted chemotherapy, became the first PD-1/PD-L1 monoantigen to be approved for urethra skin cancer in China.
II. Phase BGB-A317-204 results showed that patients with local late stage or metastatic urethra skin cancer who failed platinum-containing chemotherapy with high expression of PD-L1 monotherapy for Reilly pearl had an objective remission rate of 24.8%, a disease control rate of 38.6%, a medium total survival time of 9.8 months, and good drug safety.
has been approved for reilly-pearl single anti-urethra cancer adaptation certificate, filling the gap in clinical treatment, bringing new treatment options for clinical treatment, but also for patients to bring new treatment hope.
exploration never stops, China's original sword refers to the first-line view of the development of immunotherapy, each drug is from the late-stage malignant tumor of the backline treatment to the first-line treatment to explore.
Based on the bright eye data provided in the early study, the BGB-A317-310 study was born, which is a domestic multi-center, double-blind, randomized controlled Phase III. phase III clinical trial designed to explore the efficacy and safety of non-surgical late-stage or metastatic urethrial skin cancer in the first-line treatment of reilly bead monoantigen.
also reported on the study at the CSCO Conference.
patients in the
group will be randomly assigned 1:1 to receive a combination of terratin monoanti (200mg, Q3W) or placebo gysythadum platinum treatment, chemotherapy for up to 6 cycles, for reilly pearl monoantitor/placebo use until the disease progresses or impatient toxicity.
the main endpoints of the BGB-A317-310 study were total survival time (OS), and secondary endpoints included objective mitigation rate (ORR), mitigation duration (DOR), progress-free lifetime (PFS), and so on.
as a domestic independent research and development of PD-1 single resistance, for Reilly pearl single resistance has its own characteristics.
Fc-R design for reilly bead monoantigen minimizes binding to macrophages, thereby reducing the phagocytosty of antibody dependence, which is a potential mechanism for the treatment of drug resistance by PD-1/PD-L1 inhibitors.
In addition, the characteristics of high affinity for reilly pearl mono-resistance, the affinity for reilly-pearl mono-resistance to PD-1 is higher than that of Pabli pearl mono-resistance and Navuliyu mono-resistance to PD-1, the former is about 1/100 and 1/50 of the latter, respectively.
Based on the better anti-tumor activity in urethra skin cancer, as well as its own characteristics, I am looking forward to the BGB-A317-310 study, hoping that the study can obtain positive results and publish as soon as possible, so as to provide new treatment options for clinical practice.
At the same time, we also look forward to domestic experts and scholars can fully apply the national innovation drug for Reilly Zhu single anti-urine, in the field of urine skin cancer to carry out more exploration, so that more Chinese voice sound through the international stage.
the success of first-line immunotherapy for first-line, not plain-sailing immunotherapy, in the second-line treatment of late-stage urethra skin cancer, the exploration of first-line therapy began early.
Although individual individual PD-1/PD-L1 inhibitors (Paboliju monoantigen, atilijutin monoanti) are currently recommended for first-line treatment by the U.S. NCCN guidelines, they are limited to patients with tumor expression PD-L1, or are not suitable for any patients with platinum-containing programs, and the efficacy of single-drug therapy is relatively limited.
, the first-line immunotherapy or immunostational maintenance therapy gradually began, the results of a number of Phase III clinical trials in 2020 have also been announced.
immunotherapy was most successful on the first line in the PHASE III.JAVELIN Bladder 100 study, which included patients with local late stage or metastatic urethratic cortical cancer (CR-PR-SD) who did not develop the disease after receiving 4 to 6 cycles of gisectabin-cisplatin or/carptin therapy, and were randomly divided into 2 groups, receiving Avelumab plus best support therapy or individual best support therapy.
results showed that the mid-level OS in the Avelumab plus Best Support Treatment Group reached 21.4 months on the main endpoint OS, 7.1 months longer than the 14.3 months in the control group, with significant statistical differences (HR=0.69,95% CI:0.56-0.86; P.0.001).
javelin Bladder 100 study is the first first first line of immunotherapy to successfully improve the total survival of late-stage urethra skin cancer, rewriting clinical practice and reaching a milestone.
the results were published, the FDA quickly approved Avelumab's adaptation to first-line maintenance therapy, a new standard treatment for localized late-stage or metastatic urethroid skin cancer after first-line chemotherapy with immunosuppressant maintenance therapy.
Compared to immunosupervication therapy, people seem to expect that immunotherapy will shine in first-line treatment, after all, in the treatment of lung cancer, liver cancer and other malignant tumors have brought very good benefits to patients.
the results of the study need to be further explored in the first-line immunology treatment of urethra skin cancer.
III. Phase IMvigor130 study achieved the primary endpoint of PFS, and the CR rate of the immuno-combined standard chemotherapy group increased significantly, while the data were still immature despite the trend of benefits seen on OS, another common major endpoint.
In addition, the KEYNOTE-361 study of another immuno-checkpoint inhibitor combination standard chemotherapy program and the PD-L1 inhibitor joint CTLA-4 monoantigen for first-line DANUBE study specific data will also be published at the recent ESMO annual meeting, although no positive results, but we hope to obtain more information from the specific data of the study, for follow-up research and exploration to provide reference.
For first-line immunotherapy, the joint research programs are different, PDL1 expression status has different effects on the results, immunotherapy advantage groups, treatment programs and immunotherapy use time can be further optimized, are the direction we explore, which shows that the potential of immunotherapy has yet to be further exploited.
addition to the above-mentioned immunotherapy strategies, the immuno-combined ADC drug Enfortumab vedotin is also expected.
preliminary results from the I.b/II. Phase EV-103 study showed that the ORR in patients with local late stage or metastatic urethrial cancer treated with monoplatin mono-platinum monoantigen in Enfortumab vedotin was as high as 73.3%, and DCR was 93.3%, medium Bit PFS is 12.3 months, still not reaching the mid-OS time, it can be said that both ORR, PFS and 1 year OS rate data are significantly better than the current standard treatment, or even better than the current first-line cisplatin treatment data, the program shows surprising efficacy and safety, the current relevant Phase III clinical trials are under way, the results are worth looking forward to.
combination of immuno-checkpoint inhibitors and ADC drugs can be said to be another breakthrough in the field of advanced urethra skin cancer treatment, which is expected to provide a first-line treatment for platinum-free chemotherapy.
Overall, immune first-line maintenance therapy has rewritten the clinical practice of advanced urethroid skin cancer, and for first-line immunotherapy, it remains the focus of future research, immunotherapy and different drug federations still need more exploration, but also look forward to more clinical trial data release, to provide guidance for clinical practice.
there are still many difficult problems to be solved for domestic clinicians engaged in urethra cancer diagnosis and treatment, immunotherapy is still a relatively unfamiliar treatment, there are still many questions to be answered.
first immunotherapy also has the advantages of its treatment population, but at present we can not answer what kind of patients are the dominant population, which requires more exploration, including related immunotherapy biomarkers exploration.
Second, in the choice of immunotherapy strategy, the data we currently have is still relatively lacking, more research data are needed, and what kind of combined therapy strategy for different populations is also to be answered.
with the gradual application of immunotherapy in the clinic, including the management of adverse reactions of immunotherapy, efficacy evaluation and so on, we need more thinking, especially for urologists.
of immunotherapy requires active multidisciplinary collaboration to better provide better treatment decisions and services for our patients.
, whether the application of immunotherapy can be advanced, for urethra skin cancer peri-surgical treatment is also worth more exploration, which is also the concern of urologists.
BGB-A317-310 research design experts conclusion immunotherapy as the current field of cancer treatment darling, changed the clinical practice of a variety of malignant tumors.
for advanced urethra skin cancer, although immuno-checkpoint inhibitors are not unsymonsured in second-line treatment, they are not always easy in the exploration of first-line treatment.
First-line immunosupervical therapy, which can bring greater survival benefits to patients with advanced urethra skin cancer, should be the new standard treatment, and for other joint first-line immunization programmes, we need to explore more and obtain more research data.
As the first approved immuno-checkpoint inhibitor for urethra skin cancer adaptation certificate in China, and also the representative of innovative drugs in China, we should have high hopes for it, I believe that with the joint efforts of domestic experts and scholars, we can bring better treatment options for patients with urethra skin cancer, and bring better survival benefits to more patients.
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