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When it comes to CAR-T, it is always accompanied by the name of "miracle drug"
.
This is related to many popular classic clinical cases, the earliest is the story
of the girl Emily being saved by CAR-T therapy.
In 2012, the lives of a six-year-old American girl named Emily hung on the line
.
In the face of acute lymphoblastic leukemia, traditional chemotherapy has no effect, and doctors are helpless
.
Just when everyone was sighing for her, a miracle occurred
.
At the time, Novartis was recruiting volunteers for a Phase I clinical program (CTL019), and Emily participated with the idea of giving it a try
.
Originally, everyone just hoped that this drug could relieve some pain for this poor little girl, but they did not expect that this drug would miraculously extend Emily's life
.
This miracle drug is the world's first approved CAR-T therapy Kymriah
.
In August 2017, Kymriah was approved for marketing with its good efficacy against acute lymphoid leukemia
.
As a result, tumor treatment has entered the CAR-T era
.
However, the CAR-T era does not seem to belong to Kymriah, and its highlight moments did not last long
.
In 2022, the 6th year of approval, Kymriah seems to be unable to sell
.
/ 01 /
/ 01 /The 6th year of listing went downhill
The 6th year of listing went downhillHow long does it take for a new drug to reach peak sales after it is on the market? This is a topic
that almost every practitioner in the pharmaceutical industry will be interested in.
So, what exactly is the answer?
The time may be around
6 years.
According to a study published in 2016, Drug launch curves in the modern era.
Nature Reviews
Drug Discovery》：
Among the prescription drugs approved by the FDA from 2000 to 2002, the sales of statistically available sample drugs peaked, about 6 years
.
Of course, "6 years" is only a reference standard for a conventional category, and if it is some blockbuster drugs, the peak sales reach the age of more than 10 years
.
From these data, the world's first approved CAR-T therapy Kymriah can only move closer to the mediocre camp
.
In its 6th year on the market, Kymriah looks like it's no longer
selling.
In the first quarter of 2022, Kymriah sales were $127 million, a significant year-over-year
decline ($151 million).
At present, the decline
continues.
In the third quarter of 2022, Kymriah sales were $134 million, compared to $147 million in the same period last year
.
In fact, on a month-on-month basis, Kymriah is already in decline in its fourth full year of listing
.
As the chart below shows, Kymriah peaked at quarterly sales of $151 million in the first quarter of 2021 and then went all the way down, falling as low as $127 million
in the first quarter of 2022.
Be aware that this is built on Kymriah's treatment centers and indications for coverage, with growing case achievements
.
Clearly, Kymriah was "challenged.
"
Indeed, according to Novartis' earnings report, the root cause of Kymriah's lower sales is that the demand for patients with diffuse large B-cell lymphoma has declined significantly, resulting in varying degrees of sales in
the United States and European markets.
So, is this a patient with diffuse large B-cell lymphoma who does not need CAR-T therapy?
/ 02 /
/ 02 /The challenge of efficacy
The challenge of efficacyThe
answer is clearly no.
Although for a long time, due to factors such as price, the commercialization of CAR-T therapy has not been as strong as expected
.
But even so, there has always been
a need for CAR-T therapy in patients with diffuse large B-cell lymphoma.
Direct evidence is that sales of two other CAR-T therapies approved overseas for diffuse large B-cell lymphoma are still increasing
.
In the third quarter of 2022, Gilead's Yescarta sales were $317 million, up 81% year-over-year and 7.
4%
sequentially.
Gilead said one of the reasons for Yescarta's increase in sales is the growing
demand for patients with diffuse large B-cell lymphoma in the United States and Europe.
Meanwhile, Bristol-Myers Squibb's Breyanzi (approved only for the treatment of diffuse large B-cell lymphoma) recorded sales of $44 million in the third quarter of 2022, up year-over-year and sequentially
.
So why is Kymriah "unsellable"? The reason is probably, "involution"
.
Up to now, there are three CAR-T therapies for patients with diffuse large B-cell lymphoma overseas, namely the above-mentioned Kymriah, Yescarta and Breyanzi
.
From the clinical data, Kymriah is at a disadvantage
.
As shown in the chart below, the therapeutic effect of Kymriah, including objective response rate (ORR) and complete response rate (CR), was significantly lower than that of the other two products.
At the same time, Kymriah's side effects such as cytokine release syndrome (CRS) are significantly higher than other products
.
Judging by the pricing results, Kymriah has no disadvantage
.
Currently, the treatment price for Kymriah lymphoma is $373,000/needle, and Yescarta and Breyanzi are priced at $373,000/needle and $410,300/needle
, respectively.
With the weakest combat effectiveness and no price advantage, Kymriah did not perform as well as it should be, and it does not seem surprising
.
/ 03 /
/ 03 /The first involution to be staged overseas
The first involution to be staged overseasKymriah, which goes high and low, is not a revelation
for the global CAR-T market.
Globally, CAR-T has swept out of the sky
.
According to GlobalData
At present, there are more than 800 cell therapies for hematological tumors in the clinical stage, the vast majority of which are CAR-T therapies
.
Moreover, the indications for these CAR-T therapies are quite concentrated, clustered in five hematological tumors
: acute lymphoblastic leukemia, B-cell non-Hodgkin lymphoma, acute myeloid leukemia, multiple myeloma and chronic lymphoblastic leukemia.
Obviously, in the struggle for CAR-T therapy, high requirements are placed on product strength and commercialization strategy, as in the story of Kymriah, Yescarta and Breyanzi
.
This is even more true in
China.
In the field of CD19 CAR-T therapy, there are two approved products, namely equiracel of JW Therapeutics and aquilencel
of Fosun Pharma.
This is just the beginning, there are more than 20 CD19 CAR-T therapies in the research stage
.
It is not difficult to foresee that in the future, domestic CD19 CAR-T therapy will also stage a "involution" war
.
Not only CD19, but also other targets of CAR-T therapy, the entrants are also like crossed the river
.
For example, BCMA CAR-T therapy, although no domestic products have been approved at present, the products under research of Reindeer Medical, Keji Pharmaceutical, and Legend Bio are not far from the market, and a big war is about to break out
.
For some of the slower-progressing banal drugs, the bleak outlook is doomed
the moment the "involution" begins.
