"Shuangda combination": first-line treatment of advanced liver cancer meets milestone progress

At this year's ESMO Asia conference, Professor Ren Zhenggang of Sun Yat-sen Hospital, affiliated with Fudan University, officially announced the results of the ORIENT-32 study on behalf of the researchers.
In this study, a similar combination of Cynda Bio to T-A, Cyndili monoantigen (Dabershu) and Beval bead monoantigens (Dajutong) (the "double-up combination", equivalent to replacing PD-L1 antibodies in the T-A combination with PD-1 antibodies), also reached the main research endpoint, outperforming Sorafini at both OS and PFS endpoints.
OrIENT-32 Study ORIENT-32 is an open-label, randomized Phase III clinical study in which academician Yu Jia is the lead researcher (PI).
study included 571 non-removable Chinese liver cancer patients who had not been systematically treated and were randomly treated with a 2:1 ratio of 200 mg iv q3w plus beva bead monoantigen 15 mg/kg iv q3w) or solafini (400 mg po bid).
the main study endpoints, the OS of the shuangda group was significantly better than that of the Sorafini group, the medium OS was not reached in the combined treatment group, and the Sorafini group was 10.4 months (HR=0.569,95% CI 0.431-0.751, P.lt;0 .0001); PFS in the combined treatment group was also significantly better than Solafini, with the medium PFS in 4.5 and 2.8 months (HR -0.567, 95% CI 0.457-0.704, P.lt;0.0001), respectively).
orR in the combined treatment group was also significantly higher than in the Sorafeini group, with RECIST v1.1 as a 20.3% and 4.1% respectively, and two groups of ORRs at 23.4% and 7.1%, respectively, on the mRECIST standard.
the IMbrave 150 China Queue and ORIENT-32 here, we can see that the benefits of the dual-dad combination at both the OS and PFS endpoints are basically comparable to the T-A combination.
note that the ORR of the Shuangda combination is slightly lower than that of the T-A combination, possibly due to the impact of the new crown outbreak.
, the combined treatment group's medication and imaging assessments were more affected, the researchers reported.
considering that the study coincided with a domestic outbreak and that the synthesization was an intravenous drug, it is also reasonable to think that treatment visits are more susceptible than oral treatment programmes in Sorafini.
safety, the rates of 3-4 treatment-related adverse events (TRAEs) in the combined treatment group were comparable to 33.7 per cent and 35.7 per cent, respectively, in the Sora non-nyil group.
However, taking into account that the duration of drug use in the combined treatment group was about twice that of the sorapinie group (mid-treatment time: 6.6-7.0 months vs. 3.5 months), if compared by the rate of 3-4 levels of TRAE per unit of time, the combined treatment group was almost half that of the sorapinie group.
In addition, other symptomatic adverse events (diarrhea, rash, skin reactions in the hands and feet, hair loss) occurred mainly in the Solafini group, while bio-chemical adverse events (hypertension, proteinuria, plate plate reduction, etc.) that less affected quality of life occurred in the combined treatment group.
, it can be boldly speculated that if the quality of life of patients is subsequently assessed, the combined treatment group should also be better than the Soraferinist group.
the first line of liver cancer to meet the "milestone" the author believes that this study may change the domestic advanced liver cancer first-line standard treatment pattern.
based on the results of the ORIENT-32 study, the high probability that the Shuangda combination will be approved for first-line treatment of advanced liver cancer in China is sooner or later.
this, china's standard first-line treatment for liver cancer has four options: T-A combination, double-da combination, lenvatini and Solaphini.
CSCO 2020 First-line treatment recommendation for advanced liver cancer (Source: NextMed Database) From a patient perspective, even if the T-A combination is included in the gift, the annual treatment cost will not be too personal, is expected to be around 300,000 yuan, beyond the economic affordability of most Chinese patients.
And Xindili monoanti as the only domestic access to the health insurance directory of PD-1 antibodies, it is expected that the Shuangda combination approved for market, is expected to provide a very competitive packaging price, will greatly improve the treatment access of Chinese patients.
clinical practice, in some of the country's major centers, combined therapy has in fact become a first-line treatment of advanced liver cancer.
Although no Phase III clinical studies have confirmed the survival benefits of targeted drugs (lenvatinib or apatinib) in combination with PD-1 antibodies, the Cola combination (lenphatinib-Paboliju monoanti) and the double-A combination (Apa The ORR data in the Single Arm II Study (KEYNOTE-524 and RESCUE Study) is amazing, and its use in clinical practice is well established and may become an alternative first-line treatment in the future.
is pleased to witness that patients with advanced liver cancer at this stage have more effective options.
In addition to the recently approved T-A combination, I believe that the Shuangda combination is also about to "be among" the standard first-line treatment, and lunphatini-PD-1 antibody, double-A combination is also expected to "add bricks and mortar" to provide more options.
The biggest revelation in clinical studies is that, with the emergence of a longer first-line treatment option than Solaffinib OS, future clinical trials may not be appropriate to select Soraffinib as a control group, but to choose between the T-A combination or the double-a combination as a control group.