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CHEMOSAT Clinical Outcomes

For HCPs / Clinical Outcomes

The FOCUS study was the largest LDT (liver directed therapy) clinical trial undertaken in metastatic uveal melanoma.1-3

The phase 3 FOCUS trial evaluated the efficacy, safety and pharmacokinetics of CHEMOSAT in patients with hepatic-dominant uveal melanoma in 102 patients. [Intention to Treat n=102] 4

Primary endpoint:

Objective Response Rate
determined by IRC 4

Secondary endpoints include: 4
  • Duration of Response (DOR) by IRC
  • Disease Control Rate (DCR) by IRC
  • Overall Survival (OS)
  • Progression-free Survival (PFS) by IRC

IRC – Independent Central Review Committee; CI – Confidence Interval; ORR, DCR, OS - ITT n=102. DoR & PFS - mITT n=91 (treated patients only, per the protocol untreated patients were not followed).

Duration of Response determined by IRC 4

[95% CI: 8.31 – 17.74]

Median Progression-Free Survival determined by IRC 4

[95% CI: 6.24 - 11.56]

Disease Control Rate determined by IRC 4

[95% CI, 55.63 – 74.81]

Overall Survival (median) 4

[95% CI: 16.72 - 24.34]*

*Data continues to mature; patients will continue to be followed until May 2023.

Exploratory Analysis

Statistically significant advantage over BAC arm patients in ORR, DCR and PFS.

Supportive, pre-defined exploratory analysis were conducted, comparing patients in the CHEMOSAT vs. BAC* 4

Objective Response
(p=0.0057) [95%CI: 10.13-35.53] 4
Disease Control Rate
(p<0.0001) [95% CI: 20.64-53.59] 4

BAC - Best Alternative Care.
*The BAC arm was comprised of a total of 42 patients, originally randomised in the FOCUS trial prior to its amendment, in consultation with FDA, to a single-arm pivotal study in 2018. The eligible BAC patients were randomised to receive: Dacarbazine (n=1), Ipilimumab (n=7), Pembrolizumab (n=8), Transarterial Chemoembolization (TACE n=26).

Median Progression-Free Survival p=0.0006 (HR=0.41; [95% CI: 0.25-0.67] p=0.0004) 4
Overall Survival (Median) p=0.1764** (HR=0.730; [95% CI: 0.45-1.17] p=0.1916) 4

** Data continues to mature; patients will continue to be followed until May 2023.

Safety

Manageable and transient side effects.

Combination Therapy

Initial data from the Phase 1B CHOPIN study has shown an ORR of 85.7% using a combination of CHEMOSAT and ipilimumab plus nivolumab.

Prospective & Retrospective Studies

Treatment naïve as well as previously treated patients have shown efficacy across various endpoints.

N Treatment Line Patient Tumor Characteristics ORR OS PFS Safety Reference
Prospective Study 35 60%
treatment naïve 		No. of metastases ≥10 (57%) 72% 1 year OS - 77%
2 year OS - 43%
mOS 19.1 months 		7.5
mPFS		 Majority developed grade 3/4 haematologic events
14 grade 3 non-haematologic events		 Meijer, T., et al 20205
Retrospective Studies 81 54%
treatment naïve 		>10 lesions/>50% volume replacement (51.9%) 60.5% mOS 14.9 months 8.4
mPFS		 Grade 3/4 events were observed in 27.7% of patients Modi, S., et al 20226
51 43.1%
treatment naïve 		Oligometastatic disease ≤ 3 deposits (23.5%)
>10 lesions/>50% volume replacement (31.4%)		 47% mOS 15.3 months 8.1
months		 37.5% grade 3-4 non-haematologic events Karydis, I., et al 20171
19 31%
treatment naïve 		Not reported 53% mOS 16.7 months 14.03
months		 2 cases grade 3a (coronary ischaemia)
1 case grade 3b (transfemoral bleeding with following surgery)		 Bruning, R., et al 20202
16 25%
treatment naïve 		Hepatic lesions ranged from 3 to >20
Median tumour load of 22.5% (interquartile range 10 to 25%)		 60% mOS 27.4 months 11.1
mPFS		 Grade 3/4 events were observed in 43.8% of patients Artzner, C., et al 20197

ORR – overall response rate; PFS – progression free survival; mPFS – median progression free survival, OS – overall survival; mOS – median overall survival.

Summary of CHEMOSAT Publications

CHEMOSAT in other tumour types

To date, over 250 patients with various types of malignancies, such as ICC & CRC have received CHEMOSAT in centres across Europe.

To get involved in our upcoming studies please email EUMedicalAffairs@delcath.com