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AZ, HUTCHMED win first approval for MET inhibitor Orpathys in China

Continued approval in MET-positive NSCLC is contingent on the completion of a positive confirmatory trial

AstraZeneca (AZ) and HUTCHMED have received the first regulatory approval for their oral MET inhibitor Orpathys with an authorisation from China’s National Medical Product Administration (NMPA) for a rare type of lung cancer.

The NMPA has granted Orpathys (savolitinib) a conditional approval for the treatment of patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations, who have progressed following prior systemic therapy or are unable to receive chemotherapy.

The approval is based on results from a phase 2 trial conducted in China in NSCLC patients with this particular mutation, including individuals with the more aggressive pulmonary sarcomatoid carcinoma subtype.

In this trial, Orpathys demonstrated strong anti-tumour activity based on an independent review of objective response rate (ORR) and disease control rate (DCR).

At a median follow-up of 17.6 months, Orpathys demonstrated an ORR of 42.9% and median progression-free survival (PFS) of 6.8 months in the overall trial populations.

The PFS rate was clinically meaningful across subgroups and ORR results were also consistent regardless of prior treatment or tumour histology.

Continued approval in this setting is contingent on the completion of a positive confirmatory trial in the same patient population, as dictated by the conditional approval process.

Although only approximately 2-3% of NSCLC patients have tumours with MET exon 14 skipping alteration, more than a third of these patients live in China, AZ said in a statement.

“This approval makes Orpathys the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

“We are proud that this first-ever regulatory approval of Orpathys is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal,” he added.

In March 2020, Merck KGaA’s oral MET inhibitor Tepmetko (tepotinib) became the first from this drug class to receive approval in MET-positive NSCLC, after gaining a green light from Japan’s medicines regulator.

Since then, Tepmetko has received approval in the same patient population from the US Food and Drug Administration (FDA), with Novartis’ MET inhibitor Tabrecta (capmatinib) also winning a US authorisation for these patients recently.

Article by
Lucy Parsons

24th June 2021

From: Regulatory



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