Study Design

RYBREVANT FASPRO™ is approved across all RYBREVANT® indications as a rapid, ~5-minute subcutaneous injection1*

PALOMA-3: A phase 3, randomized, open-label trial evaluated pharmacokinetics (PK) of RYBREVANT FASPRO™ vs RYBREVANT®, both in combination with LAZCLUZE® (lazertinib)1,2

PALOMA-3 clinical study designPALOMA-3 clinical study design

*Administration time only; actual clinic time may vary.

RYBREVANT FASPRO™ effectiveness has been established based on studies of RYBREVANT®1

RYBREVANT FASPRO™ demonstrated a comparable PK profile to RYBREVANT®2

PALOMA-3 coprimary endpoints chartPALOMA-3 coprimary endpoints chart

AUC, area under the curve; C, cycle; Ctrough, trough concentration; CI, confidence interval; CV, coefficient of variation; D, day; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; ex19del, exon 19 deletion; NSCLC, non–small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.

Safety

Safety profile of RYBREVANT FASPRO™ vs RYBREVANT® arm in the PALOMA-3 trial

Lower rates of administration-related reactions (ARRs) observed with RYBREVANT FASPRO™1*

80%reduction inARRs*
13%with RYBREVANT FASPRO™

vs

66%with RYBREVANT®

PALOMA-3 clinical study AAR detailsPALOMA-3 clinical study AAR details

89% of ARRs in PALOMA-3 occurred on week 1, day 1, and median onset time of ARRs is ~2 hours. Monitor patients for any signs and symptoms of ARRs during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Patient monitoring time is up to healthcare provider discretion.1

*In clinical trials of RYBREVANT® and the Prescribing Information for RYBREVANT®, the term “infusion-related reactions” was used instead of “administration-related reactions.”

Low rates of VTE observed with RYBREVANT FASPRO™ and prophylactic anticoagulant use2

When treated with RYBREVANT FASPRO™ + LAZCLUZE® and prophylactic anticoagulant use (n=164)

VTE RATE OF7%

was observed, representing a return to baseline risk for patients with advanced NSCLC2,3

80% (n=164) of patients in the RYBREVANT FASPRO™ + LAZCLUZE® arm of PALOMA-3 received prophylactic anticoagulation for the first 4 months of treatment. Among all patients receiving RYBREVANT FASPRO™ + LAZCLUZE® (N=206), VTE rate was 11%.1,2

Majority of ARs were grades 1 and 21

ARs (≥10%) in PALOMA-31

PALOMA-3 adverse reactions chartPALOMA-3 adverse reactions chart

*Grouped terms.

  • Serious ARs occurred in 33% of patients who received RYBREVANT FASPRO™ + LAZCLUZE®1
  • Serious ARs in ≥2% of patients who received RYBREVANT FASPRO™ + LAZCLUZE® included ILD/pneumonitis (6%), pneumonia (2.4%), VTE (2.4%), and fatigue (2.4%)1
  • Death due to ARs occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), respiratory failure (1%), and sudden death (1%)1
  • The most common ARs (≥20%) were rash, nail toxicity, musculoskeletal pain, fatigue, stomatitis, edema, nausea, diarrhea, vomiting, constipation, decreased appetite, and headache1
  • Clinically relevant ARs in <10% of patients who received RYBREVANT FASPRO™ + LAZCLUZE® were abdominal pain, hemorrhoids, ILD/pneumonitis, and skin ulcer1

Select laboratory abnormalities (≥20%) that worsened from baseline in PALOMA-31*

Lab abnormalities in the PALOMA-3 clinical studyLab abnormalities in the PALOMA-3 clinical study

*The denominator used to calculate the rate is the number of patients with a baseline value and at least one post-treatment value for the specific lab test.

Prophylaxis may help reduce the risk of key ARs

Learn more

Discontinuation rates and dose modifications

  • Permanent discontinuation of RYBREVANT FASPRO™ due to an AR occurred in 13% of patients1
  • Dosage interruptions of RYBREVANT FASPRO™ due to an AR occurred in 54% of patients1
  • Dose reductions of RYBREVANT FASPRO™ due to an AR occurred in 20% of patients1

Adaptable dosing is available to help your patients manage ARs and stay on treatment4*

Learn more

*Certain types and severity of ARs require discontinuation after first occurrence.1

AR, adverse reaction; ILD, interstitial lung disease; VTE, venous thromboembolism.

References:

  1. RYBREVANT FASPRO™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Leighl NB, Akamatsu H, Lim SM, et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor–mutated non–small cell lung cancer: primary results from the phase III PALOMA-3 study. J Clin Oncol. 2024;42(30):3593-3605. doi:10.1200/JCO.24.01001
  3. Yang R, Wang H, Liu D, Li W. Incidence and risk factors of VTE in lung cancer: a meta-analysis. Ann Med. 2024;56(1):1-14. doi:10.1080/07853890.2024.2390200
  4. Data on file. Janssen Biotech, Inc.