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A few days ago, ADC Therapeutics SA announced that the FDA has approved its antibody-conjugated drug Zynlonta (loncastuximab tesirine-lpyl) for the treatment of relapsed or refractory large B-cell lymphoma (R/R DLBCL) that has previously received 2-line or above systemic therapies.
Adult patients
.
Loncastuximab tesirine (Lonca, formerly known as ADCT-402) is an antibody-conjugated drug (ADC) targeting CD19 antigen.
It consists of a humanized anti-human CD19 monoclonal antibody that is combined with pyrrobenzodiazepine (PBD) through a connector.
) Conjugated by dimer cytotoxin, it has been granted orphan drug designation for the treatment of R/R DLBCL and mantle cell lymphoma (MCL) by the FDA
.
The approval of Zynlonta is based on data from the clinical study LOTIS-2
.
The study is a multi-center, open-label, single-arm clinical study, which aims to evaluate the efficacy and safety of Lonca as a monotherapy in patients who have received at least 2 lines of system therapy for R/R DLBCL
As of April 6, 2020, the study data showed: Lonca's overall remission rate was 48.
3% (70/145), complete remission rate (CR) was 24.
1% (35/145), and partial remission rate (PR) was 24.
1 % (35/145)
.
The median response time was 1.
Zynlonta is the first CD19-targeted ADC drug approved in the world.
In December 2020, Leading Pharmaceuticals announced the formation of a joint venture with ADC Therapeutics to introduce four ADC drugs including it.
Currently, the drug has been approved for clinical use in China
.
In addition, the drug is also undergoing a phase 3 clinical trial called LOTIS 5, which aims to support Lonca combined with rituximab as a supplementary biological product license application for the second-line treatment of R/R DLBCL
Global inventory of approved ADC drugs
Antibody-conjugated drug (ADC) is a type of targeted biologics composed of antibodies, linkers and cytotoxic drugs.
It combines the targeting ability of monoclonal antibodies, high selectivity, stability, and highly effective anti-cancer potential of loaded drugs.
It can accurately distinguish between normal cells and tumor cells, and deliver cytotoxic drugs into tumor cells.
It has extremely high killing ability and is called "magic bullet"
.
In recent years, ADC drugs have become a popular research and development track in the field of medicine
According to statistics, currently 12 ADC drugs have been approved worldwide, as shown in the table below
.
Judging from the first batch of time, 2 models were approved in 2019 and 3 models were approved in 2020.
In terms of market performance, Kadcyla’s 2020 sales reached 1.
745 billion Swiss francs, Polivy and Adcetris’ sales in 2019 were 51 million Swiss francs and 1.
121 billion US dollars, respectively.
Enhertu, Trodelvy and Blenrep’s 2020 sales were 200 million US dollars and 0.
49 respectively.
Billion U.
S.
dollars and 43 million U.
S.
dollars
.
Recently, Nature published a paper predicting that the global market for ADC drugs on the market in 2026 will exceed 16.
4 billion U.
S.
dollars, of which Enhertu is approved for multiple breast cancer subgroups (HER2+, HR+/HER2- and triple-negative) and has a longer treatment time.
, Is expected to rank first in 2026 with sales of 6.
2 billion U.
S.
dollars, and Kadcyla currently leads Kadcyla due to the impact of limited treatment of HER2+ breast cancer and biosimilar drugs, with sales of approximately 2.
3 billion U.
S.
dollars in 2026, ranking third
.
With the expansion of its indications to the early stage, Padcev's sales in 2026 are expected to reach 3.
At present, China has only approved two ADC drugs, namely Takeda's Verbutuximab and Roche's Enmetrastuzumab, and China is about to usher in the first independent original ADC drug, namely Rongchang Bio's Vermicrol.
The monoclonal antibody, whose target of action is HER2, is reported to be in the countdown to its domestic listing application and is expected to be approved in June this year
.
Pfizer's inotuzumab ogamicin has also submitted a listing application in China
In addition, Chinese pharmaceutical companies have also deployed ADC drug market, such as Qilu Pharmaceutical, Kelun Pharmaceutical, Biotech, Tasly, Zhaohua Biomedicine and so on
.
In addition to independent research and development, China's pharmaceutical industry has also cooperated with other companies.