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ADC Drugs to be Launched In 2020 .pdf


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ADC Drugs to be Launched In 2020
On February 10, 2020, Clarivate Analytics released the "The 2020 Cortellis
Drugs to Watch" annual report, predicting 11 new drugs that will be launched
in 2020 and with sales expected to exceed $ 1 billion in 2024. Among these 11
drugs, 2 are anti-tumor drugs. Coincidentally, these 2 drugs are
Antibody–Drug Conjugates (ADC).
Antibody–Drug Conjugates (hereinafter referred to as ADC) are made up of
monoclonal antibodies that target specific antigens through a linker and highly
efficient cytotoxic small molecules. From the design point of view, ADC can
use the specificity of antibodies and antigens to focus cytotoxic small
molecules on target cells "precisely" and then kill them. Due to the extremely
military positioning and tracking missiles, the industry has always referred to it
as a "biological missile."

Origin: https://www.adcreview.com

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However, due to the particularity of the design concept and its structure,
the technical barriers of ADC are higher than that of general biological drugs.
Because of this, despite several decades of development, there are currently
only 7 ADC products approved worldwide. Compared with the hundreds of
thousands of chemical and other biological drugs approved in recent years,
ADC appears to be too few.
The two protagonists introduced today-Enhertu and Sacituzumab govitecan
are the latest representatives of ADC.

1. Enhertu: Rising stars against Her2-positive solid
tumors
Enhertu's original research company is Daiichi Sankyo, which is an ADC
composed of trastuzumab and ixiticon derivatives. In April 2019, AstraZeneca
and Daiichi Sankyo signed a cooperation agreement of up to 6.9 billion US
dollars for Enhertu, which made it famous. In December of the same year, the
Phase II clinical data published by the New England Journal of Medicine really
made Enhertu a hit again.
According to the published data, among 184 patients with unresectable or
metastatic Her2-positive breast cancer who have used two or more
Her2-positive treatment regimens but the disease is still progressing, Enhertu
is used as follows:
1. The objective response rate (ORR) is 60.9%, and the disease control rate is
97.3%.

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2. The duration of response (DOR) reaches 14.8 months.

3. The progression-free survival (PFS) reaches 16.4 months.

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In cases where Her2-positive breast cancer patients have exhausted almost all
Her2-targeted drugs and still cannot control disease progression, Enhertu is
still able to relieve nearly 61% of patients, and its clinical value is self-evident.
Based on the above data, Enhertu received accelerated approval from the
FDA in December 2019. In addition to "accelerated approval", Enhertu also
obtained the "fast track designation, accelerated approval, and priority review"
qualification.
For other solid tumors, Enhertu has also shown positive results in gastric
cancer. In January 2020, AstraZeneca announced that the drug has reached
the clinical endpoint in Phase II clinical trials on Her2-positive gastric cancer.
In addition to breast cancer and gastric cancer, the drug is used in colorectal
cancer, NSCLC, and clinical trials of combined PD1 inhibitors in an orderly
manner.
Based on multiple positive clinical data, Clarivate predicts that the drug's
global market will exceed US $ 2.6 billion in 2024.

Origin: Clarivate Analytics Cortellis Competitive Intelligence

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2. Sacituzumab govitecan: new hope for triple negative
breast cancer
The original company of Sacituzumab govitecan is Immunomedics, which is
formed by coupling the monoclonal antibody hRS7 targeting TROP-2 protein
with the active metabolite of irinotecan and is currently in the pre-registration
stage. Once the drug is approved, it will be the first-in-class in the TROP-2 field.
In February 2019, a piece of data from the New England Journal of Medicine
showed that among 108 patients with metastatic triple-negative breast cancer
who had received at least 2 treatment options, Sacituzumab govitecan was
treated as a single agent:
1. The overall remission rate is 33.3%, and the clinical benefit rate is 45.4%.

2. The duration of response (DOR) reaches 7.7 months.

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3. The median progression-free survival (PFS) was 5.5 months, and the
estimated overall survival (OS) was 13 months.

Although the clinical data is strong, unfortunately, due to CMC issues, the FDA
rejected the drug's marketing application in January 2019. However, in
December of the same year, Immunomedics resubmitted its marketing
application to the FDA. The current tentative PDUFA date is June 2020.
From the point of view of action mechanism, TROP-2 is abundantly expressed
in various tumor cells (such as breast cancer, cervical cancer, colorectal
cancer, renal cancer, liver cancer, lung cancer, pancreatic cancer, prostate
cancer, etc.). In theory, the drug has therapeutic potential for various solid
tumors.
In my opinion, the approval of Sacituzumab govitecan is only a matter of time,
and the drug has great potential in many solid tumors. As Clarivate predicted,
the drug will become a blockbuster in 2024, and global sales are expected to
be US $ 1.27 billion.

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Origin: Clarivate Analytics Cortellis Competitive Intelligence

Conclusion
From the moment the design concept of the ADC drug was proposed,
scientists hoped that the ADC could partially solve the limitations of the poor
efficacy of naked antibodies, and at the same time make up for the
shortcomings of cytotoxic small molecules that are too toxic to be prepared.
Reflecting this hope in the clinic, it can be found that the ADC drugs
represented by Enhertu and Sacituzumab govitecan are indeed very superior
in tumors, especially malignant tumors.
1. Enhertu is the second ADC approved for Her2-positive breast cancer after
Roche Kadcyla. It not only performs strongly in advanced Her2-positive breast
cancer, but also has the most potential for breakthroughs in solid tumors such
as gastric cancer and NSCLC .
2. Sacituzumab govitecan became the first-in-class in the TROP-2 field is
almost a matter of course. Its listing not only provides new hope for the
treatment of triple negative breast cancer, but also confirms the potential of the
new target TROP-2 in tumors.


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