Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2022

Characterization and management of adverse reactions (ARs) in patients with advanced renal cell carcinoma (aRCC) receiving Lenvatinib + Pembrolizumab (CLEAR Study) (#196)

Robert Motzer 1 , Saby George 2 , Jaime R. Merchan 3 , Thomas E. Hutson 4 5 , Xun Song 6 , Rodolfo F. Perini 6 , Ran Xie 7 , Urmi Bapat 7 , Basant Ebaid 8 , Javier Puente 9
  1. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA
  2. Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA
  3. Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA
  4. Department of Medical Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA
  5. Texas A&M HSC College of Medicine, Bryan, TX, USA
  6. Merck & Co., Inc., Rahway, NJ, USA
  7. Eisai Inc., Nutley, NJ, USA
  8. Eisai Australia Pty Ltd, Melbourne, Australia
  9. Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, Spain

Aims

In the CLEAR study, lenvatinib + pembrolizumab significantly improved efficacy outcomes versus sunitinib in first-line treatment of aRCC. Herein, we characterize key ARs (grouped preferred terms per the US prescribing information) in patients with aRCC treated with lenvatinib + pembrolizumab; we also discuss AR management strategies.

Methods

Patients were randomized (1:1:1) to lenvatinib 20mg QD PO + pembrolizumab 200mg IV Q3W (n=355); lenvatinib 18mg QD PO + everolimus 5mg QD PO (n=357); or sunitinib 50mg QD PO (4 weeks on/2 weeks off) (n=357). Key ARs in patients treated with lenvatinib + pembrolizumab are characterized.

Results

Median times (weeks) to first onset of key ARs (any grade, incidence >30%) with lenvatinib + pembrolizumab were: decreased appetite (14.6), diarrhea (20.0), fatigue (4.4), hypertension (3.0), hypothyroidism (14.3), musculoskeletal pain (6.4), nausea (14.4), rash (11.4), and stomatitis (6.6).

Key ARs resulting in dose modifications/discontinuations are shown (Table). The time to onset of grade ≥3 ARs and AR management strategies will be reported.

Conclusions

ARs due to lenvatinib + pembrolizumab were generally consistent with known safety profiles. As will be presented, clinicians play a critical role in prompt identification and AR-directed management; such management may potentially reduce treatment interruption(s) and/or lenvatinib dose reduction.

 

Table. Lenvatinib + Pembrolizumab (n=352)a

AR,b %

Lenvatinib Interruption

Lenvatinib Reduction

Pembrolizumab 
Interruption

Lenvatinib 
Discontinuation 

Pembrolizumab 
Discontinuation

Decreased appetite

4.5

7.7

2.6

0.3

0.3

Diarrhea

17.6

16.2

10.2

1.4

1.1

Fatigue

11.1

9.7

7.4

0.6

0.3

Hypertension

9.1

11.9

3.1

0.9

0.3

Hypothyroidism

1.7

1.1

1.4

0.3

0.6

Musculoskeletal pain

6.0

2.6

3.4

0.3

0.6

Nausea

4.3

5.1

1.4

0.3

0.3

Rash

5.7

4.0

2.8

1.4

2.3

Stomatitis

5.1

4.5

1.1

0.3

0

aAll safety analyses included patients who received at least 1 dose of any study drug.

bKey ARs include those with >30% incidence (all grades).

  1. Clinical trial information: NCT02811861 Funding: This study was sponsored by Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Medical writing support was provided by Oxford PharmaGenesis Inc., Newtown, PA, USA, with funding by Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.