On the same morning, Geneseeq and AstraZeneca (“AstraZeneca”) (LSE/STO/Nasdaq: AZN) united with six other industry partners to establish Astrazeneca’s Lung Cancer Early Detection Alliance. Ms. Shanshan Yang, the Head of the Early Detection Program of Geneseeq, was invited to speak at the launching ceremony: “Geneseeq is willing to work with all members of the Lung Cancer Early Detection Alliance to combine resources and expertise to empower the development and application of lung cancer early screening and early diagnosis technologies.”

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More than a third of the world’s lung cancer patients are in China and, among those with NSCLC, around 2-3% have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene. Patients with pulmonary sarcomatoid carcinoma (PSC) a rare and aggressive subtype of NSCLC usually resistant to chemotherapy, carry this mutation at a high chance of (20%-30%). This approval marks the first global regulatory approval granted for this oral, potent, and selective MET tyrosine kinase inhibitor (TKI).

The approval was based on positive results from a Phase II trial conducted in China across 32 hospitals. This multi-center, single-arm, Phase II trial screened 593 patients and identified 87 patients with MET exon 14 skipping, 70 of which were treated. At a median follow-up time of 17.6 months, savolitinib demonstrated an objective response rate (ORR) of 42.9%, a disease control rate (DCR) of 82.9%, a median time to response of 1.4 months with a median duration of response as 8.3 months, and a median progression-free survival (mPFS) of 6.8 months¹.

Nanjing Geneseeq Technology Inc. (Geneseeq) was the only designated next-generation sequencing (NGS) testing center in the approval process. Geneseeq, HUTCHMED and AstraZeneca are currently collaborating on the potential development of savolitinib companion diagnostics (CDx) kit in China for detecting MET mutations in lung cancer patients in order to provide patients with more treatment options, and better outcomes.

¹ Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. The Lancet Respiratory Medicine. June 21, 2021. DOI:https://doi.org/10.1016/S2213-2600(21)00084-9

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On April 23, 2021, AstraZeneca held an opening ceremony and twelve sub-forums for its Symposium Annual Meeting in Wuxi, China. The conference emphasized several meaningful collaborations with industry, clinical, and academic research partners in major therapeutic areas such as oncology, cardiology and nephrology. AstraZeneca’s Global Executive Vice President, the President of Greater China and International Business, Lei Wang, delivered the strategic collaboration announcement between AstraZeneca and Geneseeq at the signing ceremony. He emphasized the establishment of the Bio-Diagnostics Innovation Center, and the center’s planned R&D, educational, and promotional efforts to advance precision medicine access.

“The spotlight for the future of cancer care is on the full-course management approach to bring greater benefits to patients, including perioperative monitoring for early-to-mid stage cancers, and cancer early screening and detection,” added by Dr. Yang Shao, the founder and CEO of Geneseeq China. “The theme of today’s conference – multi-faceted collaboration, is another necessary step to achieve this goal.”

Geneseeq has provided NGS-based genetic testing service for cancer patients for more than seven years and is well-established in molecular diagnosis for late-stage cancers. For patients with early and mid-stage cancers, Geneseeq introduced SHIELDING^TM in 2021, a perioperative full-course minimal residual disease (MRD) test for solid tumors. We plan to leverage the MRD dynamic monitoring technologies to guide adjuvant therapy, prognosis and recurrence surveillance to significantly improve patient outcomes and their quality of life.

Strengthening early cancer screening and detection correlates with an increased proportion of patients diagnosed at earlier stages, which effectively prolongs the overall survival of patients and reduces the family and socioeconomic burdens caused by cancer treatment. In the fight against cancer, early screening and detection have become one of our key focuses. We developed a multi-omics-based, early cancer screening model, MERCURY. Collaborating with top cancer centers, the preliminary data shows promising performance in liver, colorectal and lung cancer patients with a sensitivity of 80%-95% and a specificity of 98%. To further validate the MERCURY model, a large-scale clinical study was launched in 2020 and is expected to enroll 100,000 participants with a five-year follow-up plan.

Under our collaboration with AstraZeneca, Geneseeq will build its fourth core laboratory in South China, in addition to its laboratories in Nanjing, Shanghai and Beijing. The two companies hope to bring highly scalable and broadly applicable clinical diagnostic tools to cancer patients soon.

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