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September 9, 2021

Amgen reports encouraging results from Phase II trial of Lumakras for NSCLC

The oral treatment offered a disease control rate of 77.5% in KRAS G12C-mutated advanced NSCLC patients with brain metastases. 

Amgen has reported favourable results from two analyses of Phase II CodeBreaK 100 clinical trial of Lumakras (sotorasib) for treating advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) patients.

A once-daily oral dose of the KRASᴳ¹²ᶜ inhibitor, Lumakras showed a positive benefit-risk profile with quick, deep and long-lasting anti-cancer activity in KRAS G12C-mutated NSCLC patients.

In a posthoc analysis of 40 patients in the CodeBreaK 100 trial, Lumakras had a 77.5% disease control rate (DCR), a median progression-free survival (PFS) of 5.3 months, and a median overall survival (OS) of 8.3 months.

On enrolment, these KRAS G12C-mutated advanced NSCLC patients had stable, already treated brain metastases.

In addition, findings showed that this DCR was in line with patients without brain metastases.

Nearly 88% of the subjects evaluable by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria sustained intracranial disease control of their stable brain lesions during Lumakras treatment.

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Two of the participants achieved complete responses of non-target lesions.

The safety profile of the treatment in the brain metastases arm was similar to already reported data.

A further exploratory descriptive analysis of the trial assessed if the mutation profile of the tumours, apart from KRASᴳ¹²ᶜ, is associated with responses or resistance of the patients to Lumakras.

An analysis of baseline tumour samples from 65 subjects showed no single genetic signature that projected Lumakras responses and ongoing assessments will be required to further detect potential targetable resistance mechanisms.

But a known causative of reduced clinical outcomes, the KEAP1 mutation, was noted in seven out of the 22 subjects with early progression and PFS of below three months.

Amgen Research and Development executive vice-president David Reese said: “We are pleased to present additional analyses for Lumakras, our newly approved KRASᴳ¹²ᶜ inhibitor, as well as a trial-in-progress poster for acapatamab, our investigational BiTE molecule being studied in NSCLC and other solid tumours.

“We look forward to the results from our CodeBreaK 101 study where we are studying a cohort of KRAS G12C-mutated NSCLC patients with untreated, active brain metastases to better understand the clinical benefit of Lumakras.”

The company also announced the design of an ongoing open-label Phase Ib trial assessing the safety and tolerability of acapatamab for treating adults with relapsed/refractory NSCLC.

A half-life extended BiTE immuno-oncology treatment, acapatamab acts on prostate-specific membrane antigen (PSMA)-expressing cancer cells.

In June 2021, Amgen reported that its antibody bemarituzumab and chemotherapy combination treatment from a trial in patients with FGFR2b+ gastric and gastroesophageal cancers met the secondary endpoint.

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