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Immutep : ESMO 2021 – INSIGHT - Stratum D Poster

09/20/2021 | 02:12pm EDT
ID 985P
ESMO 2021

#985P: Advanced safety and efficacy data from stratum D of the phase I INSIGHT platform

trial evaluating feasibility and safety of eftilagimod alpha combined with avelumab in

advanced solid tumors

Thorsten O. Goetze1,3, Daniel W. Mueller1,3, Mohammad-Reza Rafiyan2, Dragan Kiselicki2, Timursah Habibzade2, Marina Schaaf3, Regina Eickhoff3, Elke Jäger2, Salah-EddinAl-Batran1,3

1Krankenhaus Nordwest, University Cancer Center Frankfurt, Frankfurt, Germany; 2Krankenhaus Nordwest, Frankfurt, Germany;

3 Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, Frankfurt, Germany

Background

Stratum (Strat) D of the INSIGHT platform trial evaluates eftilagimod alpha (efti, IMP321) combined with avelumab in advanced solid tumors. The MHC class II agonist activates antigen-presenting cells followed by CD8 T-cell activation. Combination with PD-1/PD-L1 blockade aims at enhanced efficacy.

Methods

This trial consists of 5 strata: intratumoral (A) or intraperitoneal efti (B); s.c. efti with SOC (C) or with PD-L1 inhibition (D). Strat E is currently under development with a new efti combination. This abstract focuses on Strat D: 800mg avelumab i.v. q2w along with s.c. efti: 6mg (cohort 1, 6 pts), 30mg (cohort 2, 6 pts). Primary endpoint is safety..

Table 3: Serious adverse events (irrespective of relationship to study drug)

Cohort 1

Cohort 2

Total

800mg avelumab + 6mg efti

800mg avelumab + 30mg efti

n=6 (%)

n=6 (%)

n=12 (%)

Serious adverse event

G3

G4

G5

G2

G3

G5

G2

G3

G4

G5

Acute renal insufficiency

1

(17%)

1

(8%)

Ileus

1 (17%)

1

(8%)

Anal hemorrhage

1

(17%)

1

(8%)

Diffuse myocardial fibrosis

1

(17%)

1

(8%)

Gallbladder obstruction

1

(17%)

1

(8%)

Figure 1: Study Design

Table 1: Patient overview

Pat-ID

Cohort

Indication

Last prior therapy

PD-L1 staining / MSI /

No of

No of

No of

Best

PFS

OS

molecular markes

cycles

efti

avelumab

response

(months)

(months)

injections

adminin.

total

total

001-017

Cohort 1

Adenocarcinoma

1st line FLOT

PD-L1: nk; MSS

5

5

5

PD

1.9

19.4

stomach

001-018

Cohort 1

Adenocarcinoma

Gemcitabine / cisplatin

PD-L1: CPS 80%, MSS

3

3

3

PD*

1.7

1.7

gallbladder

additive

001-019

Cohort 1

Adenocarcinoma

3rd line TAS-102

PD-L1: nk; Pan-RAS wt

4

4

4

PD

1.8

6.1

right colon

001-020

Cohort 1

Adenocarcinoma

3rd line TAS-102

PD-L1: nk; Pan-RAS and

4

4

4

PD

2.0

21.0

rectum

BRAF wt

Adenocarcinoma

PD-L1: TPS 1%, CPS

001-021**

Cohort 1

na

2%; MSI high (Lynch-

24

12

24

PR

17.8

18.9

right colon

Syndrome)

001-022

Cohort 1

Pleural

na

Nk

16

12

16

PR

7.5

17.9

mesothelioma

Squamous cell

Def. RCTx carboplatin/

001-023

Cohort 2 esophageal

PD-L1: CPS 30%

3

3

3

SD

1.5

13.2

carcinoma

paclitaxel (56 Gy)

001-024

Cohort 2

Squamous cell anal

Def. RCTx (5-FU+

PD-L1: TPS 50%

24

12

24

PR

12.8

14.2

carcinoma

mitomoycin C)

001-025

Cohort 2

Adenocarcinoma

2nd line paclitaxel /

PD-L1: TPS 30%,

17

12

17

PR

7.4

13.4

GEJ Typ III

ramucirumab

CPS 40%

001-026**

Cohort 2

Squamous cell

Def. RCTx (cisplatin)

PD-L1 negative, MSS

9

9

9

PR

3.9

3.9

cervical carcinoma

001-027

Cohort 2

Adenocarcinoma

2nd line FOLFIRI

PD-L1: CPS 80%, MSS

4

4

4

PD

1.8

12.3

GEJ Typ II

001-028**

Cohort 2

Adenocarcinoma

2nd line FOLFIRI

PD-L1: nk; MSS, RAS

4

4

4

PD

1.9

11.8

rectum

and BRAF wt

* clinical progression, no response data according o RECIST 1.1 existing; ** low PD-L1 and MSS stable;

nk = not known; SD = stable disease; PD = progressive disease; PR = partial response; response = acc. RECIST 1.1 TPS = tumor proportion score; CPS = combined positivity score

Results

The trial was completed with 12 patients (cohort 1: gastric, gallbladder, colon,

pleural mesothelioma; cohort 2: gastric, gastroesophageal, anal, rectum, cervix uteri).

No dose limiting toxicities occurred. With data cut off from 14-May-2021, 10 serious adverse events were reported, none of them related (4 in 3 pts coh 1 [1 acute renal insufficiency grade 5 in 1 pt, 2 ileus grade 3 in 1 pt, 1 hearing impaired grade 4 in 1 pt] and 6 in 4 pts coh 2 [1 anal hemorrhage and 1 gallbladder obstruction in 1 pt, 1 eye pain and 1 feeding tube dislocation in 1 pt, each grade 3, 1 skin infection grade 2, 1 diffuse myocardial fibrosis grade 5]. 1 AE of special interest (AESI) possibly related with avelumab (sarcoidosis grade 1) occurred. 2 pts completed max treatment with 24 cycles.

In coh 1, 47 adverse events (AEs; grade 1-2, 29; grade 3, 14; grade 4, 3; grade 5, 1) occurred in 5 pts. Most common grade 1-2 AEs were nausea, pain in 33%, 33% of the pts. Most common grade 3 AEs were ileus, vomiting in 33%, 33% of the pts. 2 AEs grade 4 (hearing impaired, sepsis) and 1 AE grade 5 (acute renal insufficiency) were reported. All AEs grade 3-5 were considered causally unrelated.

In coh 2, 51 adverse events (AEs; grade 1-2, 29; grade 3, 19; grade 4, 2; grade 5, 1) occurred in 5 pts. The most common grade 1-2 AE was hypothyroidism in 33% of the pts. 1 AE grade 5 (diffuse myocardial fibrosis) was reported. Only 1 AE grade 3-5 was considered causally related (urinary tract infection grade 3 related with avelumab).

5 pts showed partial response as best response (2 coh 1: colon, pleural

mesothelioma; 3 coh 2: gastric, anal, cervical), 1 stable disease with clinical progression (coh 2) (all but one of these pts still alive), 5 disease progressions acc. to RECIST 1.1 (3 coh 1, 2 coh 2), 1 clinical progression (coh 1).

Activity was also observed in pre-treatednon-immunogenictumors. In the entire study population 75% were still alive, 66.7% of cohort 1, 83.3% of cohort 2.

Table 2: Summarized SAEs by patients

SAE

Cohort 1

Cohort 2

Total

800mg avelumab + 6mg efti

800mg evelumab + 30mg efti

n=6 (%)

n=6 (%)

n=12 (%)

Patients with at least one SAE

3

(50%)

4

(67%)

7

(58%)

Patients with at least one SAE

0

(0%)

0

(0%)

0

(0%)

with relation to study treatment

First author conflicts of interest

TOG had an advisory role for Lilly, MSD Oncology, Bayer, SERVIER, BMS and Roche, served as speaker for Lilly, MSD, Servier, and received research funding from Deutsche Foraschungsgemeinschaft, Deutsche Krebshilfe, Gemeinsamer Bundesausschuss and AstraZeneca

Eye pain

1

(17%)

1

(8%)

Hearing impaired

1 (17%)

1 (8%)

Feeding tube dislocation

1

(17%)

1

(8%)

Skin infection

1 (17%)

1 (8%)

Table 4: Most common adverse events (irrespective of relationship to study drug)

Cohort 1

Cohort 2

800mg avelumab + 6mg efti

800mg avelumab + 30mg efti

n=6 (%)

n=6 (%)

Most common AEs

G1/G2

G3

G1/G2

G3

Pain

3 (50%)

1 (17%)

2 (33%)

Nausea/Vomiting

2 (33%)

2 (33%)

1 (17%)

Injection site reaction

1 (17%)

1 (17%)

Ileus

2 (33%)

Chills

1 (17%)

1 (17%)

Fever

1 (17%)

1 (17%)

Hypokalemia

1 (17%)

1 (17%)

CRP increased

1 (17%)

1 (17%)

Dysphagia

1 (17%)

1 (17%)

Hypothyroidism

2 (33%)

Table 5: Treatment related AEs

Cohort 1

Cohort 2

800mg avelumab + 6mg efti

800mg avelumab + 30mg efti

n=6 (%)

n=6 (%)

G1/G2

G3 G4 G5

G1/G2

G3

G4 G5

Adverse reaction

Causality

Causality

Causality

Causality

Causality

Causality

Causality

Causality

Causality

efti

avelumab

efti and avelumab

efti

avelumab efti and avelumab

efti

avelumab efti and avelumab

Chills

1 (17%)

1 (17%)

CRP increased

1 (17%)

Dry eye

1 (17%)

Dyspnea

1 (17%)

Fever

1 (17%)

1 (17%)

Hypotension

1 (17%)

Hypothyroidism

2 (33%)

Injection site reaction

1 (17%)

1 (17%)

Lipohypertrophy

1 (17%)

Nausea

1 (17%)

Sarcoidosis

1 (17%)

Urinary tract infection

1 (17%)

Conclusion

Combination treatment with avelumab 800mg and efti 6mg (cohort 1) or 30 mg (cohort 2) is well tolerated, with promising signals of efficacy. No unexpected AEs were observed in the combination. In both cohorts, first signals of therapeutic efficacy were detectable which will be further evaluated.

First author contact information:

Study supported by Immutep GmbH (grant/IMP)

Thorsten O. Goetze, goetze.thorsten@ikf-khnw.de

Avelumab was provided by Pfizer, as part of an alliance

Study management contact information:

between Pfizer and Merck (CrossRef Funder ID:

Regina Eickhoff, eickhoff.regina@ikf-khnw.de

10.13039/100009945)

Study identifiers:EudraCT-No.:2016-002309-20, Clinicaltrials.gov: NCT03252938

Disclaimer

Immutep Ltd. published this content on 20 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 September 2021 18:11:05 UTC.


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