7-years-crown-follow-up


Efficacy at 7 years

 

Safety Summary

 

Therapy Management

 

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LORVIQUA can offer >7 years of PFS, the longest PFS ever reported in advanced lung cancer 1**

  • 55% of patients on LORVIQUA were alive and progression free at 7 years vs
    3% of patients on crizotinib (hazard ratio 0.19 [95% CI: 0.13–0.26])1

    • Adapted from Shaw AT, et al. Ann Oncol. 20261
    Data cutoff 31 October 2025.1


    Patients who were event free at 2 years had a 79% probability of being alive and progression free at 7 years †‡§

    Adapted from Shaw AT, et al. Ann Oncol. 20261
    Data cutoff 31 October 2025.1


    LORVIQUA can offer durable control and prevention of brain metastases at 7 years 1†‡

  • 92% of patients in the overall population remained free of IC progression at 7 years with LORVIQUA vs 16% with crizotinib (hazard ratio 0.06 [95% CI: 0.03–0.12]) 1
  • No new IC progression events observed after 30 months 1


    • Adapted from Shaw AT, et al. Ann Oncol. 20261
    Data cutoff 31 October 2025.1


    Key safety summary

    The safety profile for LORVIQUA in the 7-year follow-up analysis was consistent with that in the primary analysis.
    No new safety signals emerged    1

  • There was no increase in Grade 3 or 4 ARs in the 7-year follow-up analysis since the 5-year data update 1
  • 5% of patients discontinued LORVIQUA due to TRARs1
    - No new treatment discontinuations due to TRARs after the first 26 months1


    Adapted from Shaw AT, et al. Ann Oncol. 20261


    Therapy management considerations

    Most ARs occurred within the first 6 months and can be managed with appropriate mitigation strategies5


    Adapted from Liu G, et al. Lung Cancer. 2024


    CNS effects

  • CNS effects of any grade occurred in 43 % of patients in the 7-year analysis 1**
  • 3 patients (2%) permanently discontinued treatment due to CNS ARs1††
  • Most CNS effects are often reversible, especially when detected early and addressed with appropriate therapy management including dose modifications5


    • Weight gain

  • Weight increase occurred in 45% of patients in the 7-year analysis 1
  • No discontinuations due to weight gain were reported1,5
  • Proactive management with the goal to prevent weight gain is generally recommended 5
    - Lifestyle changes may include a low-calorie, healthy diet and regular exercise5


    • Hyperlipidaemia

  • Hypercholesterolaemia and hypertriglyceridaemia occurred in around 70% of patients in the 7-year analysis (73% and 71% respectively) 1
  • Despite a higher rate of hyperlipidaemia, cardiovascular events in patients with hyperlipidaemia were lower with LORVIQUA than crizotinib (29% vs 50% at
 7-year follow-up)1
  • Hyperlipidaemia ARs were mostly Grade 1 or 2 (hypercholesterolaemia 70% and hypertriglyceridaemia 63%) and were generally managed with lipid-lowering agents 1,5
    - Choose either rosuvastatin or pravastatin5


    • Dose modifications

  • The majority of LORVIQUA ARs were effectively managed with dose modifications 6
  • Dose reductions were used to manage ARs in about one-third of patients (34% of patients)1
  • In the 5-year analysis, more than three-quarters of evaluable events were partially or completely resolved with 1 or 2 dose reductions (79% partially or fully resolved with 2 dose reductions) 7
  • These dose reductions enabled most patients to continue to benefit from LORVIQUA 6


    • Dose reductions did not compromise systemic or intracranial efficacy1‡‡

    Adapted from Shaw AT, et al. Ann Oncol. 20261


    Adapted from Shaw AT, et al. Ann Oncol. 20261



    †The primary endpoint of PFS was met in the CROWN trial BICR-assessed primary analysis (median follow-up for PFS: 18.3 months for patients receiving LORVIQUA and 14.8 months for patients receiving crizotinib); median PFS was not estimable for the LORVIQUA arm. An unplanned INV-assessed follow-up analysis was performed at a median follow-up for PFS of approximately 83 months for patients on LORVIQUA (77.2 months for patients on crizotinib) to confirm the effect of LORVIQUA relative to crizotinib with longer follow-up. All tumour-related endpoints reported in the 7-year analysis are INV-assessed.1,3

    ‡LIMITATIONS: The results of this unplanned, INV-assessed analysis are descriptive. No formal hypothesis testing was performed given that the PFS endpoint was previously met in the CROWN trial primary analysis; results are presented descriptively.1
    §Event equals progression or death.1
    The values listed here represent median time to first occurrence for each AR. There is a distribution in which some may occur earlier or later than these median values.4
    **CNS effects included cognitive, mood, speech and psychotic effects.1
    ‡‡Based on data from 84-month follow-up of 149 patients who received LORVIQUA 100 mg once daily in the Phase 3 CROWN trial.1

    LORVIQUA® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive4.

    Adverse Reactions: The most common adverse reactions (occurring in ≥20% of patients) include edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. The most common laboratory abnormalities (occurring in ≥20% of patients) include hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia, increased AST, hypoalbuminemia, increased ALT, increased lipase, and increased alkaline phosphatase. Adverse reactions should be managed according to severity-based dose modification recommendations.

    For further information including: safety information, indication, side effects, contraindications, special warnings and precautions for use, please refer to the latest approved Israel prescribing information.


    For LORVIQUA PI Click Here



    Abbreviations:
    1L=first-line; AE=adverse event; ALK+=anaplastic lymphoma kinase-positive; aNSCLC=advanced non-small cell lung cancer;
    AR=adverse reaction; BICR=Blinded Independent Central Review; CI=confidence interval; CNS=central nervous system;
    HR=hazard ratio; IC=intracranial; INV=investigator; ITT=intention-to-treat; NR=not reached; PFS=progression-free survival;
    SmPC, Summary of Product Characteristics; TKI=tyrosine kinase inhibitor; TRAR=treatment-related adverse reaction.

    References:
    1. Shaw AT, et al. Ann Oncol. 2026; doi: https://doi.org/10.1016/j.annonc.2026.05.692; 2. Solomon BJ, et al. J Clin Oncol. 2024;42(29):3400–3409; 3. Shaw AT, etal. N Engl J Med. 2020;383(21):2018–2029; 4. The latest approved LORVIQUA Israeli prescribing information; 5. Liu G, et al.Lung Cancer. 2024;191:107535; 6. Liu G, et al. Oncologist. 2025;30(10)oyaf287; 7. Liu G, et al. Presented at ASCO 2025,30 May–3 June, Chicago, USA. Abstract 8590.


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