Orpathys approved in China for patients with lung cancer and MET gene alterations

This approval follows a priority review designation by the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) and marks the first global regulatory approval for the oral, potent, and highly selective MET tyrosine kinase inhibitor

AstraZeneca and HUTCHMED’s Orpathys (savolitinib) has been granted conditional approval in China to treat 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.

This approval follows a priority review designation by the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) and marks the first global regulatory approval for the oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI).

More than a third of the world’s lung cancer patients are in China and, among those with NSCLC, approximately 2-3% have tumours with MET exon 14 skipping alterations, a targetable mutation in the MET gene.1-3 This mutation is more common (13-22%) among patients with pulmonary sarcomatoid carcinoma (PSC), a rare and aggressive subtype of NSCLC usually resistant to chemotherapy.1,4

The approval by the NMPA was based on positive results from a single-arm Phase II trial conducted in China in patients with NSCLC with this mutation, including patients with the PSC subtype. Orpathys demonstrated robust anti-tumour activity based on an independent review of objective response rate (ORR) in the trial’s primary endpoint and its disease control rate (DCR). Continued approval is contingent upon the successful completion of a confirmatory trial in this patient population.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “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. 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. Alongside HUTCHMED, we look forward to the continued development of this medicine across a range of cancers where MET alterations and amplification are drivers of tumour growth and treatment resistance.”

Christian Hogg, Chief Executive Officer, HUTCHMED, said: “It is with great pleasure that today we announce the first regulatory approval of Orpathys globally, HUTCHMED’s third self-discovered oncology drug to be commercialized. Our collaboration with AstraZeneca in 2011 has been an important driver in the development of this novel targeted oncology drug, involving both a China-based biotech and a global pharmaceutical company. This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumours.”

In the Phase II trial, at a median follow up of 17.6 months, Orpathys demonstrated an ORR of 42.9% (95% confidence interval [CI] 31.1-55.3) and median progression-free survival (PFS) of 6.8 months (95% CI 4.2-9.6) in the overall trial population. PFS was clinically meaningful across subgroups, and ORR results were consistent regardless of prior treatment or tumour histology, including in patients with the PSC subtype (40.0%, 95% CI 21.1-61.3) and patients with other NSCLC subtypes (44.4%, 95% CI 29.6-60.0). DCR in the overall trial population was 82.9% (95% CI 72.0-90.8).

The safety and tolerability profile of Orpathys was consistent with previous trials, and no new safety signals were identified. Most adverse events (AEs) were Grade 1–2 and resolved with dose modification or discontinuation. Grade 3 or higher AEs occurred in 45.7% of patients, and treatment-related serious AEs occurred in 24% of patients. One treatment-related death was reported from tumour lysis syndrome in a patient with PSC.

Results from the Phase II trial were presented during the American Society of Clinical Oncology ASCO20 Virtual Scientific Program in May 2020, and updated results were published in The Lancet Respiratory Medicine in June 2021.

As part of the joint global development programme with HUTCHMED, Orpathys is being evaluated in combination with Tagrisso and other medicines to address tumour mechanisms of resistance in NSCLC in the ORCHARD and SAVANNAH Phase II trials for the combinations to provide longer duration of benefit, and as a treatment for other MET-driven tumours, including papillary renal cell carcinoma, and gastric and gastroesophageal junction cancers.

Tags : #LatestPharmaNewsJune23 #LatestAstrazenecaNewsJune23 #TreatmentforCancer #Treatmentforchemotherapy

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Given the rise in heart attack cases in womenApril 08, 2025
CARE Hospitals Marks World Health Day 2025 with ‘Walk for a Healthy Beginning’ at CharminarApril 08, 2025
Cancer, Obesity, Mental Health, India’s top health concerns: Ipsos Health Service Report 2024 April 08, 2025
Why Loneliness Might Be the Real Reason You're Always Falling SickApril 08, 2025
Is Your Beverage Choice Secretly Harming Your Mind?April 08, 2025
India’s Hidden Health Pandemic: Vitamin D Deficiency Affects One in FiveApril 08, 2025
Xavier University strengthens ties with India through strategic visitApril 08, 2025
Desire, Distraction, and Distress: The Untold Connection of ADHD and SexApril 08, 2025
Medical breakthrough unlocks rare disease discoveryApril 08, 2025
Elevate your space with the Crompton’s 3-star energy efficient, Avancer Swirl Ceiling Fan – a perfect combination of Aesthetics and Technology!April 07, 2025
CARE Hospitals Launches ‘SANGHAM’ Card on World Health DayApril 07, 2025
Sharda Care Healthcity partners with Prometheus School to strengthen awareness on healthy living among communities this World Health DayApril 07, 2025
Sharda Care Healthcity partners with Prometheus School to strengthen awareness on healthy living among communities this World Health DayApril 07, 2025
When the Fight Comes Back: Tahira’s Relapse and the Reality of Breast Cancer Beyond RecoveryApril 07, 2025
Beyond Hospitals and Hashtags: What World Health Day Should Really Teach UsApril 07, 2025
Dermatologist vs. Dettol: Who Should You Trust With Your Skin?April 07, 2025
The Price of Life: How a Pregnant Woman's Death Exposed the Rotten Reality of India's Healthcare SystemApril 07, 2025
Maternal and Infant Health in Focus as India Observes World Health Day 2025April 07, 2025
CARE Hospitals Promotes Safe Motherhood on World Health DayApril 07, 2025
CARE Hospitals Promotes Safe Motherhood on World Health DayApril 07, 2025