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BRIGHTSTAR trial: local consolidative therapy with Brigatinib in TKI-naïve ALK-rearranged advanced non-small-cell lung cancer


Approximately, 95% of patients who have an initial response to ALK tyrosine kinase inhibitors ( ALK-TKIs ) exhibit an incomplete response resulting in residual disease that enables the emergence of acquired resistance.
Eliminating residual disease using local consolidative therapy ( LCT ) may delay resistance emergence and improve clinical outcomes.

A single center investigator-initiated trial has assessed the safety, feasibility and efficacy of Brigatinib ( Alunbrig ) with local consolidative therapy.
Eligible patients had TKI-naïve ALK rearranged advanced non-small-cell lung cancer ( NSCLC ) with any number of metastases.
Patients were treated with Brigatinib for an induction period of 8 weeks followed by local consolidative therapy with radiation and/or surgery.

Between 12/2018 and 01/2020, 17 out of 24 planned patients were enrolled. Median age 55 ( range 33-73 ).
At study entry, 15 patients had polymetastatic disease ( more than 3 sites ) while 2 had oligometastatic disease.

As of February 1, 2020, 16 patients were evaluated for response and completed local consolidative therapy while 1 patient remained on induction Brigatinib.

The disease control rate was 100% with an objective response rate ( ORR ) of 94% ( n=15 ).

Median follow up was 8 months ( range 3-13 ) with no patients with disease progression to date.

Local consolidative therapy used was radiation ( n=11 ), surgery ( n=3 ), surgery and radiation ( n=2 ).
Among 5 patients who had surgery, 4 had lobectomy and mediastinal lymph node dissection ( MLND ), 1 had wedge resection with MLND, and 1 had adrenalectomy.
Of these, 2 had complete pathological response and 1 had complete pathological response at the primary tumor.

There were no grade greater than or equal to 2 adverse events related to local consolidative therapy, including in 7 patients treated with concurrent Brigatinib and radiation, and 6 patients treated with radiation while Brigatinib was held.

All patients continued Brigatinib after local consolidative therapy.

Brigatinib-related severe adverse effects included grade 3: increased blood levels of creatine kinase, lipase, alanine aminotransferase, amylase ( n = 1 each ) and nausea ( n = 1 ).
One patient had grade 2 pneumonitis after 2 weeks of starting Brigatinib, this resolved with steroids and Brigatinib was resumed at a lower dose.

In conclusion, Brigatinib with local consolidative therapy is safe and feasible in patients with ALK-rearranged advanced NSCLC irrespective of number of metastatic sites.
Brigatinib and local consolidative therapy may be an effective therapeutic strategy in this subset of NSCLC patients. ( Xagena )

Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020

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