DEP cabazitaxel data presentation at ASCO GI cancer meeting
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DEP® cabazitaxel data presentation at ASCO GI cancer meeting
Melbourne, Australia; 19 January 2024: Starpharma (ASX: SPL, OTCQX: SPHRY) today
announces the presentation of the positive results from its Phase 2 clinical trial of DEP® cabazitaxel
at the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium 1,
which is being held from 18 to 20 January 2024 in San Francisco, US. ASCO is the world's leading
professional organisation for physicians and oncology professionals. The ASCO GI Cancers
Symposium is the only global meeting of its kind focusing on the latest innovative science and
clinical developments in GI cancer treatment, research, and care. It brings together oncology
thought leaders, practising clinicians, novel drug developers, and GI specialists from around the
world.
Starpharma’s scientific poster presents the key results from the Phase 2 trial of DEP® cabazitaxel
in patients with advanced gastro-oesophageal cancers, announced on 18 October 20232, and
additional efficacy data for DEP® cabazitaxel in two subgroups of the gastro-oesophageal cohort
with different types of cancers: adenocarcinoma and squamous cell carcinoma (SCC). DEP®
cabazitaxel achieved disease control rates of 100% and 50%, respectively, in these advanced and
typically hard-to-treat gastro-oesophageal cancers, which have a one-year survival rate of
approximately 20%3,4.
The ASCO GI Cancers Symposium poster will be presented by Associate Professor David Pinato,
a leading Clinician Scientist and Consultant Medical Oncologist at the Imperial College London
and an investigator for the DEP® cabazitaxel study.
Associate Professor David Pinato, MD, MRCP (UK), MRes, PhD, Clinical Reader and
Consultant Medical Oncologist, Director of Developmental Cancer Therapeutics Imperial
College London, and Investigator for the trial, said:
“I am excited to share the impressive data on Starpharma's novel dendrimer formulation of
cabazitaxel with the gastrointestinal cancer community at this specialist ASCO GI cancers
conference.
“DEP® cabazitaxel showed very encouraging efficacy signals in hard-to-treat gastro-oesophageal
cancers, in addition to prostate cancer and advanced platinum-resistant ovarian cancer. The
patients in this trial had a poor prognosis with few treatment options remaining.
“In the study, DEP® cabazitaxel was well tolerated, including in patients with high-risk clinical
features. A number of our patients experienced reduced cancer-related pain, leading to reduced
opiate usage, and other improvements in quality of life.
“Based on the data and my experience with DEP® cabazitaxel, it represents a well-tolerated and
promising treatment alternative for gastro-oesophageal cancers, with the benefit of less frequent
treatment than the standard-of-care taxane option.”
The key results from the Phase 2 trial of DEP® cabazitaxel demonstrated highly encouraging antitumour activity in advanced gastro-oesophageal cancers in multiple anatomic locations
(oesophagus, gastro-oesophageal junction and stomach), including a median progression-free
survival (PFS) of 4.0 months and a median overall survival (OS) of 8.6 months.
The results for DEP® cabazitaxel in advanced gastro-oesophageal cancers compare very
favourably to standard-of-care paclitaxel treatment in patients with oesophageal or gastro1
https://conferences.asco.org/gi/attend
ASX Announcement dated 18 October 2023: Positive DEP® Cabazitaxel Phase 2 Results in Multiple Cancers
3
https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival
4
https://www.cancerresearchuk.org/about-cancer/oesophageal-cancer/survival
2
oesophageal junction cancers. DEP® cabazitaxel achieved clinically meaningful improvements
with a more than 50% longer median progression-free survival and a 29% longer median overall
survival than published data on paclitaxel administered weekly as a second-line treatment5.
Despite the majority of patients with gastro-oesophageal cancer in Starpharma’s study being
refractory to first-line therapy, DEP® cabazitaxel achieved a disease control rate (DCR) of 80%
and an objective response rate (ORR) of 30%, including stable disease (SD) for up to 27 weeks
and partial responses (PR) for up to 17 weeks in evaluable gastro-oesophageal cancer patients.
The DEP® cabazitaxel efficacy results in gastro-oesophageal cancer patients, along with highly
encouraging efficacy results in patients with metastatic castrate-resistant prostate cancer and
platinum-resistant ovarian cancer, indicate the promising clinical potential of DEP® cabazitaxel in
multiple cancer types, including cancers for which conventional cabazitaxel is not indicated6.
As reported previously, DEP® cabazitaxel was also well-tolerated, with most treatment-related
adverse events (TRAEs) being mild to moderate (Grade 1/2, 83%).
Starpharma Chief Executive Officer, Cheryl Maley, commented:
“We are pleased to present the data on DEP® cabazitaxel in gastro-oesophageal cancers at the
ASCO GI cancers meeting. Starpharma’s dendrimer platform has shown promise in multiple
therapeutic areas, and the recent Phase 2 results have clinically validated the effectiveness and
safety of Starpharma’s DEP® technology, which is designed to improve the therapeutic benefits of
drugs while minimising their side effects. We are encouraged by these results and the feedback
from patients and clinical trial investigators, which underscore the potential of Starpharma’s DEP®
technology and its ability to improve treatment outcomes for patients.”
The poster is appended.
About DEP® cabazitaxel
Developed by Starpharma, DEP® cabazitaxel is a patented, dendrimer nanoparticle version of conventional cabazitaxel, which is
marketed as Jevtana® and widely used in the treatment of prostate cancer. Unlike standard cabazitaxel, DEP ® cabazitaxel is
highly water soluble, does not contain toxic detergent-like excipients associated with anaphylaxis, and avoids the need for steroid
pre-medication. In both preclinical and clinical studies, DEP ® cabazitaxel has shown an improved side effect profile, notably
markedly reduced bone marrow toxicity demonstrated by lower rates of severe neutropenia, thrombocytopenia, and severe
anaemia, which are all reportedly experienced by a significant proportion of patients treated with Jevtana ®.
About Starpharma’s DEP® platform
Starpharma has developed a unique and valuable delivery platform known as DEP® (Dendrimer Enhanced Product), which
utilises dendrimers to improve the effectiveness and safety of conventional and new drugs. DEP® has been widely applied in
oncology but also has application to other classes of drugs, such as anti-infectives. DEP® opens new possibilities for more
controlled and precisely targeted drug delivery, enhancing therapeutic and commercial opportunities and creating significant
optionality. Additionally, the use of DEP® can create new intellectual property and extend the patent life for value-added versions
of existing drugs.
Starpharma has developed a deep pipeline of novel DEP® oncology assets. Its clinical-stage assets, DEP® cabazitaxel, DEP®
docetaxel and DEP® irinotecan, are improved versions of commonly used chemotherapeutic drugs that have demonstrated
improved anti-cancer effects and safety profiles. Additionally, Starpharma has a promising preclinical pipeline, including DEP ®
Antibody-Drug Conjugates (ADCs) and DEP® radiotheranostic products.
In addition to its internal programs, Starpharma has a number of partnered DEP ® programs with global companies, including
MSD, Genentech, Chase Sun, and AstraZeneca.
5
6
Stockton S, et al., The Oncologist, 2023;28(9):827-e822
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201023s026lbl.pdf
2
About Starpharma
Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a world leader in dendrimer technology for medical applications.
As an innovative Australian biopharmaceutical company, Starpharma is focused on developing and commercialising novel
therapeutic products that address significant global healthcare needs. Starpharma boasts a strong portfolio of products,
partnerships, and intellectual property.
Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically
manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of
branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications.
Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing
pharmaceuticals. Starpharma’s portfolio includes multiple clinical-stage oncology products, which utilise its Dendrimer Enhanced
Product (‘DEP®’) drug delivery technology, and marketed products, including VIRALEZE™ and VivaGel® BV, which utilise
SPL7013, a proprietary dendrimer with antimicrobial properties.
Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to
reduce drug-related toxicities through controlled and specified drug delivery.
In addition to Starpharma’s internal DEP® programs, Starpharma has multiple DEP® partnerships with international
biopharmaceutical companies, including AstraZeneca (oncology), MSD (Antibody-Drug Conjugates), Chase Sun (anti-infectives),
and other world-leading pharmaceutical companies. Due to the broad applicability and optionality of Starpharma’s DEP® platform,
partnered DEP® programs have the potential to generate significant future milestones and royalties.
Starpharma’s topical antiviral nasal spray, VIRALEZE™, is now registered in more than 35 countries*, including Europe, the UK,
and Asia. Starpharma’s novel non-antibiotic vaginal gel, VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention
of recurrent BV, is registered in more than 50 countries, including in the UK, Europe, Southeast Asia, South Africa, Australia and
New Zealand.
For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn.
WE Communications
Hannah Howlett
+61 450 848 064
WE-AUStarPharma@weworldwide.com
Starpharma Holdings Limited
Cheryl Maley, Chief Executive Officer
Justin Cahill, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
4-6 Southampton Crescent
Abbotsford Vic 3067
Disclosure
This ASX Announcement was
authorised for release by nonexecutive director Dr Jeff
Davies.
Forward-Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of
forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”,
“targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”,
“outlook” or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future
sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may
cause actual results to be materially different from any future results, performance or achievements expressed or implied by such
statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’
requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved
by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations
regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results,
including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally;
our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry,
and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product
candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or
expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any
forward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Clinical
case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide
to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness
of future results. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise,
representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product.
3
Efficacy and safety of dendrimer-enhanced (DEP) cabazitaxel (CTX-SPL9111) in advanced esophago-gastric cancers in a phase 1/2 trial
D.J. Pinato1, R.H. Jones2, M.D. Forster3, A.M. Joshua4, J. Korolewicz5, S. Benafif3, K. Aboud2, J. Liu4, R. Cosman4, J.R.A. Paull6, J.K. Fairley6, S.R. Edmondson6, J.F. Spicer7
1Imperial College London, London, UK, 2Velindre Cancer Centre and Cardiff University, Cardiff, UK, 3University College London Hospital NHS Trust, London, UK, 4The Kinghorn Cancer Centre, St Vincent’s Hospital, Sydney, Australia,
Abstract: 374
Poster H16
5University Hospitals Bristol and Weston NHS Foundation Trust , Bristol, UK, 6Starpharma Pty Ltd, Abbotsford, Australia, 7King’s College London, Guy’s Hospital, London, UK
Results
• Advanced esophago-gastric cancers (EGC):
- significant unmet medical need, very poor prognosis, limited available treatments
- progress rapidly with 1-year survival rate of only 20%1,2
• DEP cabazitaxel:
- novel, patented, poly-L-lysine dendrimer nanoparticle with polyethylene glycol
(PEG), and cabazitaxel covalently attached via a hydrolysable linker
- highly water-soluble, does not contain surfactants (detergents) so does not
require routine pre-medication with steroids, H2 antagonists or antihistamines,
unlike conventional formulations of cabazitaxel that contain polysorbate 80
- DEP nanoparticle size restricts it to blood volume, but allows extravasation
through leaky tumor vasculature3, enabling sustained delivery of cytotoxic drugs
within the tumor microenvironment
• Standard cabazitaxel is widely used for treatment of metastatic castrate-resistant
prostate cancer (mCRPC), but is not indicated for use in other tumor types
• Objectives of this Phase 1/2 trial were to assess preliminary efficacy and safety of
DEP cabazitaxel in patients with advanced, metastatic solid cancers
• We present the efficacy and safety of DEP cabazitaxel in a cohort of locally advanced
and metastatic EGC patients recruited to the Phase 2 part of this trial
• Phase 1 dose escalation and efficacy in mCRPC patients was presented previously4
PATIENT BASELINE CHARACTERISTICS
All
(N=15)
Adenocarcinoma
(N=9)
Squamous Cell
Carcinoma
(N=6)
Median
(Range)
61
(25 – 73)
60
(25 – 70)
68
(50 – 73)
Male
67% (10)
67% (6)
67% (4)
Female
33% (5)40% SCC
33% (3)
33% (2)
Asian
13% (2)
11% (1)
17% (1)
Black
7% (1)
0
17% (1)
Black - Arabic
7% (1)
11% (1)
0
Caucasian
67% (10)
78% (7)
50% (3)
Not specified
7% (1)
0
17% (1)
1
53% (8)
67% (6)
33% (2)
2
27% (4)
22% (2)
33% (2)
≥3
20% (3)
11% (1)
33% (2)
Oxaliplatin
60% (9)
89% (8)
7% (1)
Cisplatin
27% (4)
11% (1)
50% (3)
Taxane
27% (4)
22% (2)
33% (2)
Anti PD-1/PD-L1
27% (4)
0
67% (4)
Yes
47% (7)
22% (2)
83% (5)
Age (years)
Sex (% (n))
Race (% (n))
Prior no. lines (incl
neoadjuvant /
adjuvant) (% (n))
Selected prior
chemo-therapeutic /
biologic agents
(% (n))
Definitive Treatment
(curative intent)
(% (n))
DEP cabazitaxel nanoparticle
~ 10 - 15 nm diameter
Targeting different cancer types
20% Gastric
100% adenocarcinoma
27% GEJ
40% SCC
53%
Esophagus
100% adenocarcinoma
13%
adenocarcinoma
Methods
Increased solubility achieved with
DEP technology
Esophageal / GEJ /
Gastric (N=15)
Adenocarcinoma
(N=9)
SCC (N=6)
11% (1)
0
ECX + surgery
7% (1)
11% (1)
0
CRT
27% (4)
0
67% (4)
CRT + surgery
7% (1)
0
17% (1)
53% (8)
78% (7)
Objective
Response Median PFS Median OS
Rate
(months) (months)
(ORR)
10
80%
30%
4.0
8.6
6
100%
33%
4.1
ND
4
50%
25%
2.9
ND
*Evaluable = received ≥ 1 dose of DEP cabazitaxel and had a CT scan at ≥ 8 weeks
ORR, objective response rate (CR+PR)
DCR, disease control rate (CR+PR+SD)
ND, not determined
7% (1)
(metastatic at diagnosis)
Disease
Control
Evaluable*
Rate
(RECIST)
Tumor type
FLOT + surgery
No
•
•
•
•
DEP cabazitaxel was well-tolerated, with mostly Grade 1 (62.9%) / moderate (20%,
Grade 2) treatment-related adverse events (TRAEs), with few ≥ severe (grade 3)
events
Limited myelosuppression, including ≥ severe (grade 3) neutropenia – only 1 pt
had G-CSF treatment, 1 patient had secondary G-CSF prophylaxis
Of severe TRAEs (G3/4; 17%) most (80%) were observed in 2 patients, including
neutropenia, anemia, thrombocytopenia, fistula, sepsis, elevated liver enzymes
TRAEs were like those observed for standard cabazitaxel treatment
DEP Cabazitaxel Treatment-related Adverse Events (% of all TRAEs) in EGC patients
Grade 1
Grade 2
Grade 3
Grade 4
63%
20%
7%
10%
All Grades
n (%)
Grade 1
n (%)
Grade 2
n (%)
Grade 3
n (%)
Anemia
7 (47)
1 (7)
4 (27)
2 (13)
Neutropenia
7 (47)
2 (13)
1 (7)
1 (7)
Thrombocytopenia
2 (13)
1 (7)
44%
1 (7)
Esophago-pulmonary fistula
1 (7)
1 (7)
Nausea
5 (33)
5 (33)
Vomiting
3 (20)
2 (13)
1 (7)
4 (27)
1 (7)
• EGC patients received a median of 4.5 DEP cabazitaxel cycles (range 1-7)
• No routine steroid, antihistamine or H2 antagonist pretreatment
• Patients’ prior anti-cancer therapy: median of 1 line and median of 6 cycles
• Overall ORR in evaluable patients was 30%, overall DCR was 80%
‐ Partial responses (PR) in both adenocarcinoma and SCC subtypes
‐ Stable disease (SD) for up to 27 weeks and PR for up to 17 weeks in evaluable EGC
patients
• Median progression free survival (PFS) (all enrolled) was 4.0 months
• Median Overall Survival (OS) (all enrolled) was 8.6 months
Patients’ cancer primary distribution
SCC - Esophagus
Adenocarcinoma - Gastric, GEJ, Esophagus
20%
10%
6%
Sepsis
1 (7)
Alanine aminotransferase (ALT) increased
2 (13)
1 (7)
1 (7)
Aspartate aminotransferase (AST) increased
3 (20)
2 (13)
1 (7)
White blood cell count decreased
2 (13)
1 (7)
1 (7)
1 (7)
3 (20)
1 (7)
Nervous system Disorders
1%
Peripheral neuropathy
0%
9 (60)
5 (33)
2 (13)
2 (13)
Skin and Subcutaneous Tissue Disorders
-4%
Nail distrophy
-10%
-20%
CASE REPORT: 73-year-old man with Stage IV esophageal SCC
-36%
-44%
SCC - Esophagus
Adenocarcinoma - Gastric, GEJ, Esophagus
KEY ELIGIBILITY CRITERIA
5 (33)
Investigations
-40%
Primary tumor location
Fatigue
Infections and infestations
40%
KEY OUTCOMES
-60%
-50%
•
limited myelosuppression, lack of need for G-CSF
treatment or prophylaxis
•
no severe hypersensitivity even in the absence of routine
steroid, H2 antagonist and antihistamine premedication
• Developed multiple new lung metastases within 3 months of completing an initial
course of chemoradiotherapy with curative intent (first line)
• Achieved partial response following 5 cycles of DEP cabazitaxel:
• 44% overall decrease in tumor burden
• 45% reduction in size of a lung metastasis
• Disease control maintained for 24 weeks
Conclusion
DEP cabazitaxel administered as a monotherapy, once every 3 weeks exhibited highly
encouraging anti-tumor activity in >1L, advanced EG cancers:
• multiple anatomic locations (esophagus, GEJ and stomach)
• different histological sub-types: adenocarcinoma and SCC
• included many patients who were refractory to 1st line therapy
• achieved excellent efficacy responses:
• median progression-free survival (PFS) of 4.0 months
• median overall survival (OS) of 8.6 months
• 30% ORR and 80% DCR in evaluable patients
The DEP cabazitaxel results compare very favorably to standard-of-care paclitaxel
treatment in patients with esophageal or gastro-esophageal junction cancers, with DEP
cabazitaxel achieving a more than 50% longer median PFS and a 29% longer median OS
than paclitaxel administered weekly as a second-line treatment5. The DEP cabazitaxel
efficacy results in advanced EGC patients, along with highly encouraging efficacy results
in patients with mCRPC and platinum-resistant ovarian cancer, indicate the promising
clinical potential of DEP cabazitaxel in a range of cancer types, including cancers for
which conventional cabazitaxel is not indicated6.
ACKNOWLEDGEMENTS
We would like to thank the patients and their families, and caregivers, for their participation in this
study. Starpharma would like to thank participating investigators and their study team for their support
on this study, and their dedication to patients, particularly during the challenges attributable to the
COVID-19 pandemic.
E
400-09
GEJ
100-09
Sub-type
SCC
SCC
Ad.
Ad.
Ad.
SCC
Ad.
Ad.
SCC
Ad.
Metastatic at diagnosis
N
N
N
Y
Y
N
Y
Y
N
N
Study sponsored by Starpharma Pty Ltd, Abbotsford, Australia
References
N
N
Y
Y
N
Prior chemo lines
3
3
2
1
3
1
1
1
1
2
• Patients with advanced or metastatic solid tumors
• Measurable disease or evaluable tumor marker
• Eastern Cooperative Oncology Group (ECOG)
performance status 0-1
• Life expectancy ≥ 12 weeks
• Symptomatic brain metastases or untreated spinal
cord compression
• Absolute neutrophil count (ANC) < 1.5×109/L;
platelet count < 100×109/L; haemoglobin < 10 g/dL
• Bilirubin > ULN, or AST or ALT > 1.5 x ULN
• Concurrent or planned treatment with
inhibitors/inducers of CYP3A4/5
• Symptomatic grade 1 or ≥ grade 2 peripheral
neuropathy (PN)
• Anti-tumor therapy ≤ 30 days or 5 half-lives prior to
dosing
Prior anti-PD-1 / PD-L1
Y
Y
N
N
N
Y
N
N
Y
N
CT Scans of cancer metastasis in lung
Best % Reduction in Tumor Biomarkers (where applicable)
Weeks on Study – Evaluable Patients
mostly mild / moderate TRAEs
E
400-15
N
30
•
GEJ
400-28
Y
25
CLINICAL FEATURES INCLUDING POOR NUTRITIONAL STATUS
E
400-22
N
20
durable responses in esophageal, GEJ and gastric cancers
concomitant tumor biomarker reductions
GEJ
400-11
N
15
•
•
E
400-16
N
10
HISTOLOGY
G
400-29
1st line Best Response of PD
5
ENCOURAGING ANTI-TUMOR ACTIVITY IN ADVANCED
ESOPHAGO-GASTRIC CANCERS OF BOTH ADENOCARCINOMA AND SCC
E
400-33
Exclusion Criteria
Median = 19 weeks (range 8-27)
HIGHLY
E
400-08
Inclusion Criteria
0
3 (20)
General Disorders and Administration Site Conditions
45%
(Q3W DOSE REGIMEN)
Gastrointestinal Disorders
60%
TIME ON STUDY
Grade 4
n (%)
Blood and Lymphatic System Disorders
Best % Reduction in Tumor Target Lesion Size (RECIST 1.1)
FLOT (chemotherapy) + surgery = 5-FU + leucovorin + oxaliplatin + docetaxel + gastrectomy
ECX (chemotherapy) + surgery = epirubicin + cisplatin + capecitabine + esophagectomy
CRT = chemoradiotherapy (fluoropyrimidine / paclitaxel + platinum) + 50.4 Gy radiotherapy
CRT + surgery = carboplatin + paclitaxel + 40.4 Gy RT + esophagectomy
DEP CABAZITAXEL MONOTHERAPY
WELL-TOLERATED IN ADVANCED CANCER PATIENTS WITH HIGH-RISK
Treatment-Related Adverse Events (Most Extreme Grade) Experienced by ≥ 10% Patients or ≥ Grade 3
(N=15)
System Organ Class
MedDRA Preferred Term
Unsolicited investigator reports of improvements in patient Quality of Life (QoL) factors
included:
• Reduced cancer-related pain and opiate usage
• Improved performance status
• Weight gain
17% (1)
• Patients with RECIST 1.1 measurable advanced EGC (squamous cell carcinoma [SCC]
and adenocarcinoma) were enrolled to receive open label DEP cabazitaxel
• DEP cabazitaxel, equivalent to 20 mg/m2 cabazitaxel (recommended dose),
administered intravenously (IV, ~60 min infusion), once every 21 days (3-weekly)
• Antitumor activity assessed by RECIST v1.1 and, where applicable, tumor biomarker
levels such as CEA and CA 19-9; safety assessed by physical and hematological
examinations, and adverse events graded according to CTCAE v4.03
EU Clinical Trials Register EudraCT: 2017-003424-76
SAFETY OVERVIEW
DEP Cabazitaxel
RECIST best % change (nadir vs baseline)
Background
PHASE 2 ESOPHAGO-GASTRIC CANCER COHORT EFFICACY OVERVIEW
CEA
0%
0%
0%
-67%
N/A
-50%
-40%
N/A
-20%
N/A
CA 19-9
9%
-33%
38%
-81%
>100%
-35%
-77%
-99%
-5%
-11%
PD = Progressive Disease
CEA = carcinoembryonic antigen
CA 19-9 = cancer antigen 19-9 / carbohydrate antigen 19-9
BASELINE
POST-TREATMENT
45% reduction in size of a lung metastasis
1. https://www.cancerresearchuk.org/about-cancer/oesophageal-cancer/survival
2. https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival
3. Kaminskas LM, Porter CJ. Adv Drug Deliv Rev, 2011;63(10-11):890-900
4. Jones RH, Pinato DJ, Joshua A, et al. Ann Oncol, 2022:33(suppl_7):S616-S652
5. Stockton S, Catalano P, Cohen SJ, et al. The Oncologist, 2023;28(9):827-e822
6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201023s026lbl.pdf
Corresponding Author: JP, Starpharma Pty Ltd, jeremy.paull@starpharma.com
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