Cordrayda's sixth adaptive disorder was approved in the single-drug first-line treatment of head and neck squamous cell carcinoma

Recently, The new adaptive application for the single anti-Paboli pearl single anti-injection (relevant acceptance number JXSS2000010) in the NMPA status changed to "in approval", which means that its single-drug first-line treatment tumor expression P The new adaptation of metastatic or non-removable reoccessive head and neck squamous cell carcinoma (HNSCC) of D-L1 (Joint Positive Score (CPS)≥20) is about to be approved in China, and is the sixth adaptation to be approved in China.
7th among global malignancies, head and neck malignancies are reported to account for about 600,000 new cases each year.
in China, head and neck malignancies account for about 3% of systemic malignancies, the common histological type is squamous cell carcinoma, more than 60% of head and neck squamous cancer patients at the time of diagnosis for local late stage or metastasis.
statistics, China's annual new incidence of head and neck tumor patients more than 135,000, the number of deaths of about 70,000, far more than other countries and regions, and showed an increasing trend year by year.
and in patients with head and neck squamous cancer, about 50% relapse and occur more than 2 years.
the five-year survival rate was only 3.6% for patients with relapse or metastasis that failed in first-line treatment.
platinum-based chemotherapy has been a routine first-line application of relapsed/metastatic head and neck squamous cancer for decades, but survival is not ideal.
Until September 2019, The PD-1 monoanti-navuliyu monoantimmune was approved by NMPA for the treatment of relapsed or metastatic head and neck squamous cell carcinoma (TPS≥1%) that progressed during or after treatment with a platinum-containing program, and the treatment of head and neck squamous cell carcinoma in China ushered in a new era of immunotherapy.
In addition, it is worth mentioning that in March this year, Merck's EGFR targeted drug sitoxysin is approved in China for sitoxysydantic platinum and fluorouracil, first-line treatment of relapsed/metastatic head and neck squamous cell carcinoma, and the program was recommended by the 2020 new CSCO Head and Neck Oncology Guidelines for Level I experts (evidence level 1A).
,084 million U.S. dollars in sales in 2019, according to the company, which is currently the world's highest-sales PD-1 single-resistance.
Since its launch, the drug has received a number of adaptations, including melanoma, non-small cell lung cancer, lymphoma, urethra skin cancer and more than 20 tumor adaptations, and has recently been approved by the FDA for the treatment of triple-negative breast cancer, in addition to the drug has been approved for two open-ended cancer treatments.
in China, Paboli juju monoantigen has been approved for 5 adaptations, namely, local late stage or metastasis melanoma (2018/07), first-line treatment without EGFR/ALK mutation metastasis non-scale NSCLC (2019/03), single-drug first-line treatment PD-L 1 Tumor Proportion Score (TPS) ≥1% of EGFR gene mutation-negative and APK-negative localized late stage or metastatic NSCLC (2019/09), first-line therapeutic metastatic scaly NSCLC (2019/11) and esophageal squamous cancer (2020/06).
this time, Pabli pearl monoantigen is about to be approved in China first-line head and neck squamous cell carcinoma adaptation is based on phase III large randomized controlled study KEYNOTE-048 results: 1) in PD-L1 expression positive (CPS≥20) patients, K drug compared TOTREME program (chemotherapy and EGFR targeting drug), the median total survival (OS) from 10.20 8 months extended to 14.9 months, reducing the risk of death by 39%, while reducing the proportion of significant side effects; 2) in all patients, K-drug combined chemotherapy was extended from 10.7 months to 13.0 months, OS was extended from 10.7 months to 13.0 months, the risk of death was reduced by 29%, and safety was basically equivalent;
abroad, the K drug was approved by the FDA in 2019 for first-line treatment of head and neck squamous cell carcinoma.
And the researchers published data on the four-year survival rate of the KEYNOTE-048 study at the 2020 annual meeting of the European Society of Oncology (ESMO) in September, which showed that the two-year survival rate of patients treated with traditional standard treatment was 19.7%, compared with 35.3% for immunotherapy, 8.0% for patients with traditional standard treatment and 21.6% for immunotherapy group.
that K drug can be approved in Japan in the first line of treatment head and neck squamous cell carcinoma, the benefit of domestic patients.
domestic PD-1 single anti-japanese war opened, one after another to declare the approval of new adaptive disorders so far, the domestic has approved 6 PD-1 single resistance, of which 2 imports, 4 domestic, see the table below.
of the six PD-1 mono-antis, only Xinda Bio's Xindili mono-resistance entered the 2019 National Health Insurance.
can be seen from the table above, at present, Paboli pearl monoanti and Hengrui medicine's Karelli pearl single resistance approved adaptation disorders are more.
However, according to insight database, so far these PD-1 single resistance have been declared new adaptive disorders, as detailed in the table below, in addition, there are 3 new domestic PD-1 single anti-declaration listing, namely, the Saipali single resistance, Jia and biological Jano single resistance and Kangfang biological / Zhengda Tianqing Pa ampuri single resistance.
the filing time, these listing applications are mainly concentrated this year, it is expected that the approval time of new adaptations will also be more concentrated.
According to the company's financial results, these four domestic PD-1 single resistance is also not to be underestimated, Xindili single resistance, Tripley single resistance, for Reilly pearl single resistance and Karelli pearl single resistance in the first three quarters of 2020 sales of 1.5 billion yuan, more than 700 million yuan, 662 million yuan and about 3 billion yuan (Karelli Pearl single anti-cause Q2, Q3 specific sales are not announced, 3 billion yuan is the industry estimate), of which Riley Pearl single-resistance in March this year officially listed sales, 662 million yuan sales are still very considerable.
In addition, it is worth mentioning that the current domestic approval of 5 PD-1 single resistance (except Xindili monoanti) and 2 PD-L1 single resistance (i.e., degree Valliyu single resistance and Atili zhu single resistance) are included in the 2020 medical insurance preliminary examination list.
, however, from the current health care policy, these new immunologic drugs, efficacy, price, scope of adaptation, the availability of alternative treatment options, etc. are the key to access to health care.
now that the NHS is in the final stages of scrutiny, who will laugh last will have to wait for the official announcement.
But in order to enter health insurance, enterprises are also striving, such as Hengrui in the fourth quarter launched the Carelli Pearl single anti-"full-year drug cost 39600 yuan" big promotion, and before even if the annual cost of the gift drug Karelli pearl single resistance is about 120,000 yuan.