Challenge K drug: Chia Tai Tianqing PD-L1 combined with Anlotinib initiates first-line NSCLC Phase III clinical trial

On September 24, the Insight database showed that CP Tianqing’s PD-L1 monoclonal antibody TQB2450 was registered for a phase III clinical trial, combined with anlotinib for the first-line treatment of NSCLC, compared with Merck’s K drug pembrolizumab

From the Insight database (http://db.

According to CP Tianqing’s previous press release, this clinic has launched nationwide recruitment on August 16.

TQB2450 is an innovative fully humanized anti-PD-L1 monoclonal antibody with a new sequence independently developed by Chia Tai Tianqing

TQB2450 project time axis

From the Insight database (http://db.

The clinical trial initiated this time is the sixth phase III clinical study initiated by TQB2450, targeting locally advanced (phase IIIB/IIIC), metastatic or recurrent ( phase

TQB2450 Phase III clinical trial launched in China

From the Insight database (http://db.

As a PD-1 product that has won the throne of the drug king, K drug has so far been approved for 30 indications in the United States

However, the giants still followed suit
.
GSK's Dostarlimab initiated a phase 2 non-squamousNSCLC clinical trial head-to-head K drug (NCT04581824) in August 2020, and AstraZeneca's PD-1/CTLA-4 dual antibody MEDI5752 was registered in the Phase 1 clinical trial in 2018 Also tried to challenge K drug (NCT03530397)
.

To look into the country's interior, Insight According to incomplete statistics, the previous tumor immunotherapy K will conduct clinical drug product as a control drug only three, namely Cinda biological PD-1 monoclonal antibody Dealey letter, Dunlop bio-PD-1Pratellizumab (HX008 ) and BeiGene PD-1 tislelizumab , and now another PD-L1 monoclonal antibody TQB2450 is added
.
However, the latter two are both combination therapy VS single agent
.

Dealey letter mAb had in January 2020 registered at ClinicalTrials.
gov a single-center Phase II clinical (NCT04252365 ) , the first-line treatment of NSCLC, chaired by Professor Wu Yilong study recruited 20 patients; Pu Teli mAb in 2020November launched a head-to-head K phase 2/3 clinical medicine , first-line treatment of advanced or metastatic non-squamous NSCLC, study chaired by Professor Zhou Caicun, domestic recruited 60 patients ( CTR20202387 ); for Raleigh natalizumab is In February this year, a large international multi-center phase III clinical trial was registered at ClinicalTrials.
gov, combined with TIGIT monoclonal antibody versus K drug, and 605 people were recruited globally, including 242 people in China (NCT04746924/ CTR20211464 , AdvanTIG-302 study)
.

At the beginning of July, CDE released the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines" that caused industry shocks for soliciting comments
.
It pointed out that when choosing a positive drug as a control group, “the best treatment method/drug in clinical practice should be provided to the subjects as much as possible, and the safety and effectiveness of the choice should not be uncertain in order to improve the success rate and efficiency of the clinical trial.
Or the treatments that have been replaced by better drugs", this expression has aroused great concern in the market.
For a time, "head-to-head" "First-in-class" and so on have become hot topics of discussion in the industry
.