Investigational Rinatabart Sesutecan (Rina-S) Shows Promising
Anti-Tumor Activity as Single Agent in Heavily Pretreated Patients
with Ovarian and Endometrial Cancers in Phase 1/2 Clinical Trial
Media Release
COPENHAGEN, Denmark; September 15, 2024
- Treatment with rinatabart sesutecan
(Rina-S) showed encouraging response rate in heavily
pretreated patients with ovarian cancer in dose expansion
cohort
- Responses with Rina-S were observed across FRα
expression levels
- Phase 3 trial will further evaluate the safety and
efficacy of Rina-S at 120
mg/m2 in patients with
advanced ovarian cancer
Genmab A/S (Nasdaq: GMAB)
announced today new data from the Phase 1/2 study of rinatabart
sesutecan (Rina-S), an investigational folate receptor-alpha
(FRα)-targeted, Topo1 antibody-drug conjugate (ADC), demonstrated a
confirmed objective response rate (ORR) of 50.0% (95% CI) in
ovarian cancer patients treated with Rina-S 120 mg/m2
once every 3 weeks (Q3W), regardless of FRα expression levels.
These data were from the dose expansion part of a multi-part study
evaluating the safety and efficacy of single-agent Rina-S in
ovarian cancer (OC) and endometrial cancer (EC). These results, and
additional findings from the study, were presented at the European
Society of Medical Oncology Congress 2024 (ESMO) in Barcelona,
Spain.
Part B of the study randomized 42 previously-treated patients
with histologically or cytologically confirmed advanced OC
(epithelial ovarian cancer, primary peritoneal cancer or fallopian
tube cancer) to Rina-S 100 mg/m2 (n=22) or Rina-S 120
mg/m2 (n=20). Ninety-five percent of patients in the 120
mg/m2 group were identified as platinum-resistant
ovarian cancer (PROC) as were 90.9% of patients in the 100
mg/m2 group. In patients receiving Rina-S 100
mg/m2, results showed a confirmed ORR of 18.2% compared
with 50.0% among patients receiving 120 mg/m2. Results
for 100 mg/m2 and 120 mg/m2 respectively also
included: complete response: 0 (0%) and 1 (5.6%); partial response
in 4 (18.2%) and 8 patients (44.4%); stable disease in 15 (68.2%)
and 7 patients (38.9%); disease progression in 3 patients (13.6%)
and 1 patient (5.6%). Only one patient in the 120 mg/m2
treatment arm was not evaluable. With a median on study follow-up
of 24 weeks, all confirmed responses with the 120 mg/m2
dose were ongoing at the time of data cutoff. The disease control
rate (DCR) was 86.4% and 88.9% (95% CI: 65.3-98.6), respectively.
Based on these results, Rina-S 120 mg/m2 has been
selected for further evaluation in a Phase 3 trial for patients
with advanced ovarian cancer, which is expected to start in
2024.
"Ovarian cancer presents a significant challenge, especially for
those with advanced or recurrent cases, where treatment options and
prognosis are often limited," said Elizabeth Lee, MD, a medical
oncologist in the gynecologic oncology program at
Dana-Farber. "The encouraging Phase 1/2 data for Rina-S
demonstrates the potential for future treatment options for
patients. We are looking forward to additional data from
tumor-specific dose expansion cohorts.”
In this Phase 1/2 study, common treatment-emergent adverse
events (TEAEs) included anemia, neutropenia, nausea,
thrombocytopenia, leukopenia, fatigue, vomiting, alopecia, and
diarrhea. Dose reductions and treatment discontinuations were
infrequent. No signals of ocular toxicities, neuropathy or
interstitial lung disease (ILD) were observed.
“We are encouraged by the data from this ongoing Phase 1/2 trial
evaluating Rina-S in a patient population that is in need of new
therapeutic options and believe the data support the potential for
Rina-S to demonstrate anti-tumor activity beyond first-generation
folate receptor-alpha based therapies,” said Jan van de Winkel,
Ph.D., President and Chief Executive Officer of Genmab. “Genmab is
pioneering technologies that aim to transform the treatment of
cancer and other serious diseases. We are committed to evaluating
the full potential utility of Rina-S in patients with ovarian,
endometrial and other solid tumor cancers.”
About Rina-S Phase 1/2 Clinical Trial
(NCT05579366)
This open-label, multicenter Phase 1/2 study is designed to
evaluate the safety and efficacy of rinatabart sesutecan (Rina-S)
as a single agent Q3W at various doses in solid tumors that are
known to express FRα. The study consists of multiple parts
including Part A dose-escalation cohorts; Part B tumor-specific
monotherapy dose-expansion cohorts; Part C platinum-resistant
ovarian cancer (PROC) cohort; and Part D combination therapy
cohorts.
Part A looked at dose escalation in patients with locally
advanced and/or metastatic solid tumors, including epithelial
ovarian cancer, endometrial cancer, breast cancer, non-small cell
lung cancer, and mesothelioma. In patients with OC (n=32) and EC
(n=11), treatment with Rina-S 100-120 mg/m2 (n=23 and
n=5, respectively) demonstrated a confirmed Objective Response Rate
(ORR) of 30.8% (95% CI: 14.3-51.8) with Partial Responses (PR) in 8
patients (30.8%), Stable Disease (SD) in 15 patients (57.7%), and
Progressive Disease (PD) in 3 patients (11.5%). The Disease Control
Rate (DCR) was 88.5% (95% CI: 69.8-97.6), and the median Duration
of Response (DOR) was 35.3 weeks (95% CI: 20.14-NE).
Part B includes the B1 cohort, which is a dose expansion study
in patients with histologically or cytologically confirmed advanced
OC (epithelial ovarian cancer, primary peritoneal cancer, or
fallopian tube cancer). Patients were randomized 1:1 to 100
mg/m2 and 120 mg/m2 dose groups with a median
age ranging from 62.5 to 64.5 years across both groups.
Ninety-point nine percent of patients in the 100 mg/m2
group were identified as platinum-resistant ovarian cancer (PROC)
as were 95% of patients in the 120 mg/m2 group. Study
participants were previously treated with a median of 3 prior lines
of therapy (range 1-4) including bevacizumab (90.9% in the 100
mg/m2 group and 90.0% in the 120 mg/m2 group
respectively), PARP inhibitors (68.2%; 65%) and mirvetuximab
soravtansin (18.2%; 19%). Responses in patients with OC were
observed across FRα expression levels.
About Ovarian Cancer
Ovarian cancer is a major global health issue, with over 320,000
new cases diagnosed annually worldwide.i It ranks as the
eighth most common cancer and the eighth leading cause of
cancer-related deaths among women globally.ii The
disease is often diagnosed at an advanced stage due to its subtle
and non-specific symptoms, such as abdominal bloating, pelvic pain
and difficulty eating.iii Platinum-based chemotherapy,
often in combination with targeted therapies and surgery, has been
the standard treatment in ovarian cancer across all
stages.iv,v Approximately
70-90% of women with advanced-stage ovarian cancer worldwide
experience a recurrence after initial treatment.vi
Ovarian cancer has a low five-year survival rate, which varies
significantly by region, but generally hovers around
30-50%.vii,viii
About Rinatabart Sesutecan (Rina-S;
GEN1184)
Rinatabart Sesutecan (Rina-S; GEN1184) is a clinical-stage,
FRα-targeted, Topo1 ADC, currently in Phase 2 development for the
treatment of ovarian cancer and other FRα-expressing solid tumors.
Based on the data from the ongoing clinical trials, Genmab intends
to broaden the development plans for Rina-S within ovarian cancer
and other FRα-expressing solid tumors. In January 2024, the U.S.
Food and Drug Administration granted Fast Track designation to
Rina-S for the treatment of patients with FRα-expressing high-grade
serous or endometrioid platinum-resistant ovarian cancer.
About Genmab
Genmab is an international biotechnology company with a core
purpose of guiding its unstoppable team to strive toward improving
the lives of patients with innovative and differentiated antibody
therapeutics. For 25 years, its passionate, innovative and
collaborative team has invented next-generation antibody technology
platforms and leveraged translational, quantitative and data
sciences, resulting in a proprietary pipeline including bispecific
T-cell engagers, antibody-drug conjugates, next-generation
immune checkpoint modulators and effector function-enhanced
antibodies. By 2030, Genmab’s vision is to transform the lives of
people with cancer and other serious diseases with
knock-your-socks-off (KYSO®) antibody
medicines.
Established in 1999, Genmab is headquartered in Copenhagen,
Denmark, with international presence across North America, Europe
and Asia Pacific. For more information, please visit Genmab.com and
follow us on LinkedIn and X.
Contact:
David Freundel, Senior Director, Global Communications &
Corporate Affairs
T: +1 609 430 2481; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
This Media Release contains forward looking statements. The
words “believe,” “expect,” “anticipate,” “intend” and “plan” and
similar expressions identify forward looking statements. Actual
results or performance may differ materially from any future
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i World Cancer Research Fund International.
https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/.
Accessed August 2024.
ii World Ovarian Cancer Coalition.
https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/.
Accessed August 2024.
iii Dilley, James et al. Ovarian cancer symptoms, routes to
diagnosis and survival - Population cohort study in the 'no screen'
arm of the UK Collaborative Trial of Ovarian Cancer Screening
(UKCTOCS). Gynecologic oncology vol. 158,2
(2020): 316-322. doi:10.1016/j.ygyno.2020.05.002.
iv Ovarian Cancer Research Alliance.
https://ocrahope.org/patients/diagnosis-and-treatment/treatment-options/chemotherapy/.
Accessed August 2024.
v American Cancer Society.
https://www.cancer.org/cancer/types/ovarian-cancer/treating.html.
Accessed August 2024.
vi Ovarian Cancer Research Alliance.
https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/.
vii European Institute of Women's Health.
https://eurohealth.ie/policy‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/.
Accessed August 2024.
viii American Cancer Society. Stages of Ovarian Cancer.
https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed August 2024.
Media Release no. i14
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
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