In recent years, the global new drug research and development fever is high, but new drug research and development has the characteristics of high cost investment, long return period, and high research and development failure rate, and it is not easy for a new drug to successfully go to market
.
Since 2022, many multinational pharmaceutical companies, including Merck, Sanofi, Roche and other multinational pharmaceutical companies, have reported the failure of new drug research and development, which has aroused concern and heated discussion
in the industry.
On August 17, Sanofi announced that the company's phase III AMEERA-5 study of oral selective estrogen receptor degrader ambenestrant combined with piperacilly for the treatment of ER+/HER2-advanced breast cancer patients had not reached the primary endpoint, and decided to terminate the global clinical development program for
the drug.
Amcenestrant is an experimentally optimized oral selective estrogen receptor degrader (SERD) that binds to estrogen receptors or ER in breast cancer cells, inhibiting their normal function and triggering degradation so that it is no longer used
by tumor cells.
Previously, in March, Sanofi had said that its phase 2 AMEERA-3 clinical trial evaluating ambenestrant failed to achieve the primary endpoint
of improving progression-free survival (PFS).
Since the beginning of this year, Sanofi's new drug research and development has been repeatedly frustrated, in addition to amcenestrant, a Phase 3 trial of Dupixent for the treatment of chronic spontaneous urticaria cooperated with Regeneration Yuan was stopped
due to ineffectiveness.
Judging from public information, it is not surprising that the failure of new drug research and development has occurred in multinational pharmaceutical companies, including many cases of phase III clinical failure.
In early August, Merck announced the failure
of a Phase III clinical trial of its PD-1 inhibitor Keytruda (pambolizumab, often referred to as K) in combination with Lenvima (lenvatinib/levatinib).
It is reported that the efficacy hypothesis of merck's clinical trial study called "LEAP-002" is that the efficacy of pambolizumab + levatinib in the treatment of HCC (i.
e.
, hepatocellular carcinoma) patients is better than that of levatinib monotherapy
.
However, the data results showed a "reversal", compared with the treatment of levatinib alone, although the clinical data such as the overall survival of patients treated with pambolizumab + levatinib showed an improvement trend, the results did not have statistically significant improvement
.
On 3 August, Merck and Eisai announced that the phase III LEAP-002 study in the first-line treatment of patients with advanced unresectable hepatocellular carcinoma with Lenbima in combination with k-drug did not reach the main focus
.
In addition to the above-mentioned pharmaceutical companies, this year, Roche's crenezumab in the Alzheimer's disease prevention initiative project Phase II clinical trial and PO-L1+TIGIT joint first-line treatment of non-small cell lung cancer Phase III clinical research have not reached the main research endpoint
.
From the perspective of the reasons for the failure of new drug research and development, some are because the project is not correct, some are too late in the research and development declaration, and there are other companies in the front on the track, in addition, some companies are because of the disconnect between new drug research and
development and production transfer.
Overall, although the market for innovative drugs brought about by favorable policies and capital increases is broad, the examples of the failure of new drug research and development of these multinational pharmaceutical companies will also give other pharmaceutical companies a warning, even if they have gone through phase I and phase II clinical trials, they may also encounter challenges in phase III, in addition, many pharmaceutical companies terminate new drug research and development because the track is crowded, on the popular track, how to break through is a major problem
.
The industry believes that for some drugs with competitors in the market, such as PD-1, it is the key
to obtaining more indications or stabilizing its position and increasing revenue.
For example, Merck's K drug is exploring new indications, but the situation is not as simple as imagined, and it has encountered walls
in the fields of prostate cancer, small cell lung cancer, liver cancer, stomach cancer and so on.
Behind a large number of clinical trials, enterprises need to continue to invest in funds, and need to face the impact of competitors, these factors are a big test
of enterprise research and development capabilities, financial resources and endurance.
