Recently, the FDA held a three-day meeting on the accelerated approval of PD-1/L1 immuno-oncology drugs.
On the first day of the meeting, the expert group, one of the largest participants in the field, Roche’s Tecentriq (atelizumab) ) Discussed.
Atelizumab is a PD-L1 inhibitor, Roche has always hoped to use it to make up for the lost market in the competition of biosimilar drugs.
In the end, the experts voted 7:2 to retain the approval of the drug during further research.
In March 2019, PD-L1-positive patients' progression-free survival (PFS) results based on the IMpassion130 study of atelizumab combined with Abraxane (albumin paclitaxel) in the treatment of PD-L1-positive metastatic triple-negative breast cancer (TNBC) (7.
4 months vs.
8 months, HR: 0.
6, P <0.
0001), Atelizumab has obtained accelerated FDA approval for the treatment of PD-L1 positive, previously untreated, unresectable locally advanced or mTNBC adult patients.
The full approval of this indication depends on the results of the IMpassion131 study.
The IMpassion131 study is a confirmatory test for mTNBC indications.
The study evaluated the efficacy of atilizumab + paclitaxel vs.
placebo + paclitaxel in the first-line treatment of previously untreated, inoperable, locally advanced or metastatic TNBC patients.
The primary endpoint of the study is the PD-L1 positive population and the ITT population (Intent-to-treat population) median progression-free survival (mPFS).
However, the results of the study showed that Tecentriq combined with paclitaxel did not extend the lifespan of TNBC patients in PD-L1-positive or ITT populations.
The mPFS of PD-L1-positive patients were 6.
0 and 5.
7 months, and the mPFS of ITT population were 5.
7 and 5.
6 months, respectively.
There are several factors that can explain the difference between the results of "IMpassion130" and "IMpassion131".
These factors include routine changes before medication, differences in trial statistical design, and different median follow-up times.
After technical issues disrupted the meeting, experts supported the continued approval of this indication with 7 votes in favor and 2 votes against it so that investigators could collect more data on this combination therapy.
In the report, Roche expressed confidence to see the benefits of atelizumab combined with Abraxane in the treatment of TNBC patients in the next confirmatory trial.
At the same time, Dr.
Stephen Chui, medical director of Roche Genentech's tumor product development group, said that due to the current lack of effective treatments for TNBC, he agreed to keep this combination therapy on the market.
Chui said that Roche discussed several ways to obtain confirmatory clinical trial data with the FDA in December last year, including repeating the original key clinical trial.
He added that a more practical solution is to wait for 3 ongoing research data on relevant patient populations, including clinical trials for the treatment of early-stage TNBC patients.
Tomorrow, another indication of atelizumab approved by the FDA will also face the discussion of the expert group.
This indication is the first-line treatment of locally advanced or metastatic urothelial cancer (mUC) that is not suitable for platinum-based chemotherapy.