First-line breast cancer! Hengrui "Darcili" new indication report on the market

On October 20, the official website of CDE showed that Hengrui Pharmaceutical's CDK4/6 inhibitor darcilil new indication was reported on the market
.
According to the information disclosed by the company before, this indication is likely to be: first-line treatment of HR+/HER2- advanced breast cancer
.

From: CDE website

Darcili (R&D code: SHR6390), independently developed by Hengrui, was approved for marketing just last year and is the first approved domestic CDK4/6 inhibitor
.
According to the Insight database, the earliest clinical application for the drug began in 2014, took 7 years to develop, successfully submitted a second-line therapy marketing application in April 2021, and was approved
by the NMPA in only 8 months.
On August 29 this year, Hengrui announced that the phase III clinical trial DAWNA-2 (ClinicalTrials.
gov registration number: NCT03966898) for first-line indications has reached the main endpoint, which is likely to be a new indication declared this time
.
At the ESMO Annual Meeting in September, DAWNA-2 research data has been published (#LBA16) :D AWNA-2 research results were first published @2022 ESMO

From: Screenshot of the Clinical Results Module of the Insight Database (http://db.
dxy.
cn/v5/home/)

The 456 patients enrolled in the DAWNA-2 study were randomized to darcilil + letrozole/anastrozole or placebo + letrozole/anastrozole on a 2:1 ratio, with a median follow-up of 21.
7 and 21.
4 months
, respectively.
Primary endpoints were investigator-assessed PFS, and secondary study endpoints included PFS, OS, ORR, DoR, Clinical Benefit Rate (CBR), and Safety
as assessed by an Independent Review Committee (IRC).
The results showed that the investigator-assessed PFS in the darsili group and placebo group were 30.
6 vs 18.
2 months, respectively, on the primary study endpoint; HR 0.
51, one-sided p-value < 0.
0001
.
For secondary study endpoints, the PFS assessed by the Independent Review Committee (IRC) in the darcili and placebo groups were NR vs 22.
5 months, HR 0.
50, and unilateral p-value < 0.
0001, respectively, and for other secondary study endpoints, the ORR was 57.
4% vs 47.
7%, CBR 86.
8% vs 79.
7%, and the DoR was 15.
0 months
in the darcili and placebo groups, respectively 。 CDK4/6 inhibitors have been hugely successful since their introduction, with combined sales exceeding $7.
7 billion in 2021
just looking at the three major global players.

Global sales of the three CDK4/6 inhibitors in the past 3 years

From: Insight Database Annual Report Sales Data

However, in China, it is not easy
to stand out in this market.
Pfizer pibociclib was first marketed as early as 2018 and was approved in tablet and capsule double dosage forms, but 3 generic drugs have been approved and 9 more are in the process of being declared
.
Lilly's abeceli was approved for marketing in 2020, which is the most approved indication in China, and the first-line, second-line, and adjuvant therapy indications are all rolled out
.
Novartis Bercilli also submitted a listing application last year, which has not yet been approved
.
In terms of the dimension of domestic original research drugs, Hengrui is the first and only one at present, and its progress can be said to be far ahead, when other domestic companies have not yet begun the listing application process, Hengrui has begun to push the indications forward and expand to the front line
.
However, the implicit pressure is still not small, because there are 6 similar products (including Lerociclib introduced by Genor Biopharma) that are already in the phase III development stage, and they are only one foot
away from being declared for marketing.

The highest domestic CDK4/6 innovative drug in phase III clinical trials

From: Insight Database Project Progress Module