Bayer’s pan-tumour precision medicine PBS listed in brain, lung and soft tissue cancers

Pharma News: Starting from August 1, Bayer’s Vitrakvi (larotrectinib) has been listed on the Pharmaceutical Benefits Scheme (PBS) for treating advanced non-small cell lung cancer (NSCLC), soft tissue sarcomas, and brain tumours (including glioma, glioneuronal tumours, and glioblastoma) with the NTRK (neurotrophic tyrosine receptor kinase) gene fusion.

Dr Stephen Luen, Medical Oncologist at the Peter MacCallum Cancer Centre, highlighted that precision medicine is becoming increasingly common as biomarker testing advances.

“Cancer treatments that harness DNA profiling and genetic information are the new frontier in precision oncology. By focusing on what’s driving the cancer rather than where the cancer is in the body, we can treat patients with the right medicine at the right time,” he said.

“Vitrakvi is an example of a pan-tumour precision medicine, meaning it can be used to treat cancers with a particular genetic feature regardless of the type of cancer or where it is found in the body.”

He further added, “Around one-in-five cancers are caused by ‘gene fusions’. These cancers often respond poorly to non-targeted treatments, so ensuring timely access to targeted treatments is critical. We will definitely see more tumour-agnostic therapies in the years to come.”

In a matching-adjusted indirect comparison (MAIC), Vitrakvi demonstrated a 57% reduction in the risk of death compared to Roche’s Rozlytrek (entrectinib). Both drugs showed similar tumour shrinkage capabilities, with Vitrakvi achieving a response in 67.3% of patients compared to 53.6% for Rozlytrek.

However, significantly more patients experienced no sign of cancer while on Vitrakvi; the complete response rate for Vitrakvi was 20.3%, versus 6.8% for Rozlytrek. Additionally, Vitrakvi’s response duration was longer at 32.5 months compared to Rozlytrek’s 12.9 months.

Despite Rozlytrek potentially being a better option for patients with brain metastases due to its ability to cross the blood-brain barrier, a head-to-head randomised control trial between the two drugs is not feasible due to the rarity of TRK fusion cancer.

Dr Eduardo Pimenta, Bayer ANZ Medical Director, expressed his company’s excitement about securing government support to expand access to Vitrakvi. “

Ensuring Australian patients have access to this therapy has been an absolute priority for our company,” said Dr Pimenta. “At Bayer, we continue to research and develop therapies to address the unmet needs of cancer patients, in Australia and globally.”

Since 2019, Bayer has invested over $10 million in Australia to support 11 oncology clinical trials across 54 sites, enrolling 83 Australian patients. This includes four patients with NTRK-positive tumours participating in trials to assess Vitrakvi’s impact on cancer progression and survival.

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