Bring the potential of ROZLYTREK® to life

The first and only
approved agent to
deliver a meaningful response with intracranial efficacy in ROS1+ NSCLC1

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The first and only approved agent to deliver a meaningful response with intracranial efficacy in ROS1+ NSCLC1

ROZLYTREK is a potent, selective ROS1 inhibitor, demonstrating antitumour activity within the CNS1

The efficacy of ROZLYTREK for patients with ROS1+ NSCLC was evaluated in three Phase I and II trials1,2

Study design

Efficacy was evaluated in 161 patients with ROS1+ NSCLC from three global, single-arm, open-label Phase I and II trials1,2

Three Phase 1 and 2 ROZLYTREK trials in 161 ROS1 inhibitor-naïve patients with ROS1+ advanced NSCLC

*16 patients were enrolled into dose-escalation studies.
† With ≥6 months of follow-up from date of first dose.
‡ As evaluated by Blinded Independent Central Review.

Safety was evaluated in 504 adult and paediatric patients across multiple biomarkers and tumour types as an integrated analysis of 4 clinical trials: ALKA-372-001, STARTRK-1, STARTRK-2 and STARTRK-NG1

Patient characteristics

ROZLYTREK was studied in 161 ROS1 inhibitor-naïve patients with ROS1+ NSCLC1

Over one-third of patients had CNS metastases3*

Brain icon showing patients that had CNS metastases at baseline

*As evaluated by investigator.

Over one-third of patients were treatment naïve3*

Bar chart showing proportion of treatment-naïve, 1 prior therapy, 2 or more prior therapies

The majority of patients were female1

Diagram showing proportion of female, male and age of patients in the trial

The majority of patients had an ECOG-PS score of 0 or 11

Bar chart showing patient distribution for ECOG-PS 0, ECOG-PS 1 and ECOG-PS 2

ECOG-PS, Eastern Cooperative Oncology Group Performance Status.

Almost two-thirds of patients were never smokers1

Cigarette icon showing percentage of patients who were never smokers

Efficacy

ROZLYTREK delivered clinically meaningful responses in ROS1+ NSCLC irrespective of baseline CNS metastases1,3

  • ORR
  • DOR
  • PFS
  • OS

ROZLYTREK delivered a clinically meaningful ORR of 67.1%1,3

Diagram of confirmed overall ORR, with and without baseline CNS metastases

*As evaluated by Blinded Independent Central Review.

†As evaluated by investigator.

Long-lasting response in ROS1+ NSCLC3

Coloured strip showing median duration of response (DOR) with ROZLYTREK

*As evaluated by Blinded Independent Central Review.

ROZLYTREK delivered almost 16 months of median PFS3

Median PFS (N=161)3

Graph showing median PFS with ROZLYTREK in ROS1 fusion+ NSCLC

*As evaluated by investigator.

†As evaluated by Blinded Independent Central Review.

ROZLYTREK offers high rates of survival over time1,3

Diagram of ROZLYTREK median OS and OS event-free rate

CNS efficacy

ROZLYTREK crosses the blood–brain barrier and results in a clinically meaningful response in ROS1+ NSCLC patients with CNS metastases1,5

ROZLYTREK is a weak substrate of P-glycoprotein and therefore is able to achieve clinically meaningful concentrations in the CNS1,5

ROZLYTREK offers high progression-free rates in the CNS6

ROZLYTREK CNS progression-free rate in all patients, and with or without CNS mets at baseline

Baseline CNS metastases assessed by investigator. Time to CNS progression: only confirmed CNS progression counted as an event (death censored).

*As regular CNS scans were not mandated by the protocol, CNS follow-up of patients without baseline metastases was not comprehensive but based on symptomatic progression or routine CNS scans where customary.

Over three-quarters of patients with measurable baseline CNS metastases had a durable intracranial response – with 12.5% achieving a complete response1

Brain icon with coloured strip showing IC-ORR, IC-CR and IC-PR with ROZLYTREK

* As evaluated by Blinded Independent Central Review.

† Patients with measurable baseline CNS metastases.

‡ Nine of 24 patients had received intracranial radiotherapy to the brain within 2 months of their first dose of ROZLYTREK.

IC-ORR shows efficacy in the brain4

Brain icon with strip showing ORR in CNS metastases can only be proven with intracranial response

The first and only approved agent to deliver a meaningful response with intracranial efficacy in ROS1+ NSCLC1

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for details on how to report adverse reactions.

Footnotes

CI, confidence interval; CNS, central nervous system; CNS PD, central nervous system progressive disease; CNS-TTP, time to central nervous system progression; DOR, duration of response; IC-CR, intracranial complete response; IC-DOR, intracranial duration of response; IC-ORR, intracranial objective response rate; IC-PR, intracranial partial response; ITT, intent-to-treat; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; QD, once-daily; ROS1, c-ros oncogene 1; rwPFS, real world progression-free survival; TTD, time-to-treatment discontinuation.

 

References

  1. ROZLYTREK Summary of Product Characteristics, 2020.
  2. Drilon A, et al. Lancet Oncol 2020;21:261–270.
  3. Krebs MG, et al. Efficacy and safety of entrectinib in locally advanced/metastatic ROS1 fusion-positive NSCLC: an updated analysis. Presented at the ESMO Virtual Congress 2020: 19–21 September 2020.
  4. Data on file. Genentech, Inc.
  5. Fischer H, et al. Neuro Oncol 2020;22:819–829.
  6. Dziadziuszko R, et al. Efficacy of entrectinib in patients with NTRK or ROS1 fusion-positive NSCLC with CNS metastases at baseline. Presented at the ESMO Virtual Congress 2020, 19–21 September 2020.