CHENGDU,
China, Sept. 28, 2024 /PRNewswire/ -- From
September 25th to
29th, the 27th China Clinical Oncology Congress and the
2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of
oncology from all over China
gathered together to discuss the hotspots at the forefront of
clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co.,
Ltd. ("Kelun-Biotech", 6990.HK) presented multiple clinical
research results and progress of TROP2 ADC sacituzumab
tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the
conference.
TNBC
On the afternoon of September 27,
Academician Binghe Xu from the Cancer Hospital of the Chinese
Academy of Medical Sciences gave an oral presentation and paper
discussion on the results of the Phase III OptiTROP-Breast01 study
of sacituzumab tirumotecan (sac-TMT) in patients (pts) with
previously treated locally recurrent or metastatic triple-negative
breast cancer (TNBC) in the Innovative Drugs Clinical Data
Session.
The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to
8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with
chemotherapy; The sac-TMT group had a 68% reduction in risk of
disease progression or death compared to the chemotherapy group (HR
0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts
with TROP2 H-score > 200, the median PFS was 8.3 months with
SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to
0.46). The median OS was not reached (95% CI, 11.2 to NE) with
SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The
sac-TMT group had a 47% reduction in risk of death compared to the
chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005).
Compared to the investigator's choice of chemotherapy, sac-TMT for
metastatic TNBC patients showed statistically and clinically
significant improvements in PFS and OS, with a manageable safety
profile, and could be a new and effective therapeutic option for
this group of patients.
Binghe Xu said, "Breast cancer is
a highly prevalent malignant tumor in the world, threatening
women's lives and health, among which, triple-negative breast
cancer is also known as 'the most toxic' breast cancer due to its
poor therapeutic effect. The future direction of advanced
triple-negative breast cancer treatment is precise and stratified
treatment. Sac-TMT can help to meet more treatment needs of
patients, and may be expected to become the new standard of
second-line treatment for advanced triple-negative breast cancer in
the future. For the research and development of ADC, domestic
enterprises have gone through the stages of catching up and running
parallel to each other, and now they have become an important force
in the global ADC innovation technology, and we believe that one
day, patients with advanced triple-negative breast cancer can get
more effective treatment through ADC innovative drugs."
NSCLC
On the afternoon of September 28,
Prof. Wenfeng Fang from the
Affiliated Cancer Hospital of Sun
Yat-sen University orally reported the results of the Phase
II OptiTROP-Lung01study, a first-line treatment for patients with
advanced non-small-cell lung cancer (NSCLC) with sac-TMT in
combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the
session of Clinical Data of Innovative Drugs, with a paper
discussion.
Pts with treatment naive advanced NSCLC without actionable
genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W +
KL-A167 1200 mg Q3W (cohort 1A,130 Pts) or SKB264 5 mg/kg Q2W +
KL-A167 900 mg Q2W (cohort 1B,133
Pts) in a non-randomized manner. After median follow up of 14.0 mo
and 6.9 mo for cohort 1A and 1B, the
ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and
median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of
69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending
confirmation), DCR was 100% and median PFS was not reached with
6-mo PFS rate of 84.6% for cohort 1B.
Prof. Wenfeng Fang said, "The
emergence of ADC drugs is epoch-making. The dual-drug regimen of
sac-TMT combined with immunotherapy is leading a new direction in
the exploration of first-line treatment for advanced NSCLC, with
very stunning efficacy observed in the preliminary study data. In
the future, the potential for the application of sac-TMT in the
treatment of NSCLC is worth looking forward to, and sac-TMT is
expected to provide diversified treatment options and better
survival benefits for more patients, both in the driver-negative
and EGFR-mutated patient populations."
CC
On the morning of September 28,
Professor Jing Wang from Hunan
Cancer Hospital orally reported the results of Efficacy and Safety
of sac-TMT Plus Pembrolizumab in patients with recurrent or
metastatic cervical cancer. Pts with R/M CC who had progressed on
or after platinum-doublet chemotherapy and received no more than 2
systemic therapies for R/M disease were enrolled.38 pts were
treated and followed up for at least 17 weeks or 2 tumor
assessments. The median follow-up was 6.2 mo, The ORR was 57.9%
(22/38, 3 unconfirmed), with 3 complete responses. Responses were
also observed in pts were pre-treated with anti-PD-1 based therapy.
Median PFS was not reached and 6-mo PFS rate was 65.7%.
Professor Jing Wang said,
"Cervical cancer highly expresses TROP2, and previous studies have
suggested that the overexpression ratio is more than 90%. High
TROP2 expression is closely related to the poor prognosis of tumor
patients, and it may also be related to the sensitivity of some
drug therapies, which makes it a good target to explore. It is
believed that with these promising results, more studies will
emerge in the field of gynecologic oncology in the future to
further validate these findings and bring hope to a wider range of
cancer patients."
EC/OC
On the morning of September 28,
Dr. Zhuo Yang from Liaoning
Provincial Cancer Hospital shared the results of safety and
efficacy of sac-TMT in pts with previously treated advanced
endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2
Study. In the endometrial cancer cohort, 44 EC pts were enrolled
and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2
prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and
DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS
rate of 47.5%.
40 OC pts were enrolled and median follow-up time was 28.2 mo.
All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3
prior lines). 87.5% of pts were platinum-resistant. The ORR was 40%
(16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI:
3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2
IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was
61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed)
respectively. In the pts with platinum-resistant (n=35), mPFS was
6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5,
NE).
Prof Danbo Wang said, "Ovarian cancer and endometrial cancer
have their own epidemiological characteristics, and the incidence
rate of endometrial cancer in developed cities in China is increasing year by year, and it may
become the top gynecological malignant tumor in Chinese women in
the future. In contrast, ovarian cancer is characterized by
insidious onset, high late detection rate and high mortality rate.
Exploring new therapeutic strategies to overcome platinum
resistance and improve the survival rate of ovarian cancer patients
is a key direction for future research. Sac-TMT shows great
potential in the treatment of advanced endometrial and ovarian
cancers. It has not only achieved remarkable results in terms of
efficacy, but also well controlled safety. I believe that in the
future research and application, it will become a leader in the
field of ADC innovative drug development and bring new hope to more
gynecological oncology patients."
With a caring heart, Kelun-Biotech is committed to solving unmet
clinical needs in China and around
the world. By focusing on its own technological strengths,
Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant
clinical value and excellent cost-effectiveness, and to enhance the
benefits for clinical patients. In the future, we will continue to
accelerate the R&D and clinical progress of our drug
candidates, enhance our integrated drug development capabilities,
and contribute to the realization of Healthy China 2030.
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SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.