On December 19, AstraZeneca announced that the drug Imfinzi, as a monotherapy for patients with advanced non-small cell lung cancer, failed to achieve its primary goal
of improving overall survival compared to platinum-based chemotherapy.
AstraZeneca said Imfinzi failed
in a phase III trial called "PEARL" in patients whose tumor cells expressed high levels of PD-L1 or in a subgroup of patients with a lower risk of early death.
Imfinzi is known to belong to immunotherapy, which uses antibodies to block or bind foreign substances in the body to enhance the body's defenses against cancer
.
The results of this trial showed that in both subgroups, patients in the Imfinzi group did not have a statistically
significant improvement in OS compared to the SoC group (platinum-based chemotherapy).
But in the subgroup with PD-L1 expression levels > 50%, OS improved
in patients in the Imfinzi group.
In terms of safety, the safety and tolerability of Imfinzi are consistent with previous studies, and no new safety signals
have been found.
This is not the first time Imfinzi has failed in a phase III trial, having previously failed to meet the primary endpoint
in a clinical phase III CALLA trial in patients with locally advanced cervical cancer.
Specifically, in March, AstraZeneca issued a statement saying that in the 770 patients involved in the study, Imfinzi (durvalumab) combined with chemoradiotherapy did not achieve statistical significance
in improving progression-free survival (PFS) compared with CRT therapy alone.
The CALLA trial is a randomized, multicenter, double-blind, global phase III clinical trial
.
In fact, drug research and development has always had the characteristics of
long process, large investment and high failure rate.
Every year, major pharmaceutical companies around the world will have a number of clinical trials
that attract a lot of attention, but they come to an abrupt end at a critical stage.
Recently, a number of pharmaceutical companies have also announced the failure of new drug research and development, and the suspension or termination of clinical trials
.
Among them, there are companies that have failed as many times as AstraZeneca
.
For example, on December 7, Relmada Therapeutics announced that its drug REL-1017 for the treatment of major depressive disorder did not meet the primary endpoint in the phase III RELIANCE-I clinical study, and the patient's depression did not improve significantly, that is, the clinical trial of depression drugs failed
again.
It is understood that REL-1017 is a novel NMDA receptor channel blocker that preferentially targets the GluN1-GluN2D hyperactive channel and maintains physiological glutamatergic neurotransmission
.
The FDA has granted REL-1017 Fast Track designation as an adjunct treatment
for major depression.
According to the results of the trial published by Relmada, on a rating scale measuring symptoms of depression, taking its four-week course of medication with standard care did not result in a statistically significant improvement
compared to placebo.
The setback is the second failure of the depression drug since October, with REL-1017 tested as monotherapy in the first trial, and the latest study designed to evaluate the efficacy
of REL-1017 as an adjunct to standard depression treatment.
Relmada believes that neither study has achieved the desired results, which is common
in drug trials for psychiatric-related disorders.
It is worth mentioning that Relmada's share price fell further as a result of this news, with stocks that have lost most of their value since October falling by nearly 50%
again.
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