Loxo Reports Promising Phase 1 Data for RET Inhibitor LOXO-292; Illumina Acquires Edico Genome to Enhance Genomic Data Analysis

1. Olaparib (Lynparza) Approved in the EU for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer

Olaparib tablets (300 mg, twice daily) have recently been approved by the European Medicines Agency for maintenance treatment in patients with platinum-sensitive recurrent high-grade epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are in complete or partial response after platinum-based chemotherapy, regardless of their BRCA mutation status. This EU approval is based on two randomized clinical trials (SOLO-2 and Study 19), which demonstrated that olaparib, compared with placebo, reduced the risk of disease progression or death in patients with platinum-sensitive recurrent ovarian cancer.

2

Illumina Acquires Edico Genome to Accelerate Genomic Data Analysis

On May 15, Illumina announced the acquisition of Edico Genome, a leading provider of next-generation sequencing (NGS) data analysis acceleration solutions. Edico Genome’s DRAGEN™ Bio-IT Platform (DRAGEN) leverages off-the-shelf field-programmable gate array (FPGA) technology and proprietary software algorithms to reduce data footprint and time-to-results. The acquisition is expected to close in Illumina’s second fiscal quarter, ending June 30, 2018.

3

QiuZhen Medicine Secures Strategic Investment from Yangzi State-owned Capital

Yangzhou State-owned Assets Investment Group’s Yangzhou Technology Venture Capital Equity Investment Fund has taken an equity stake in QiuZhen Medical Technology (Beijing) Co., Ltd. The two parties have jointly invested RMB 50 million to strategically develop the upstream and downstream segments of the oncology industry chain, establish a tumor biobank, and construct a tumor atlas and big data center for the Chinese population.

4

Meinian Onehealth to Acquire Meiin Gene for RMB 388 Million

Recently, Meinian Onehealth Healthcare Holdings Co., Ltd. announced that it plans to acquire a 33.42% stake in Meiyingen Health Technology (Beijing) Co., Ltd., held by Shanghai Tianyi Asset Management Co., Ltd., for RMB 387.672 million using its own funds. Upon completion of this transaction, Meinian Onehealth will hold a total of 50.56% of the shares in Meiyingen, becoming its controlling shareholder.

Clinical NewsClinical Updates[ NO.17 2018 ]

1

Loxo Announces Latest Data: Precision Therapy Achieves 69% Overall Response Rate

Loxo Oncology announced that it will present interim data from the Phase 1 clinical trial of its promising novel drug, LOXO-292, at the American Society of Clinical Oncology (ASCO) Annual Meeting in early June. The abstract, titled “A Phase 1 Study of LOXO-292, A Potent and Highly Selective RET Inhibitor, in Patients with RET-Altered Cancers,” was also selected as a “Best of ASCO” presentation.

This novel drug is a selective RET inhibitor that effectively inhibits RET gene fusions and mutations in preclinical studies. In a global Phase 1 clinical trial, researchers enrolled patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), thyroid cancer, and pancreatic cancer, all of whom harbored RET abnormalities. The study found that the overall response rate (ORR) was 69% (95% CI: 50%-84%) among evaluable patients positive for RET gene fusions. Among patients with lung cancer, the ORR was 65%. Researchers noted that these results demonstrate significant antitumor activity of LOXO-292 in patients with RET-mutated cancers.

2

Innovent Biologics Announces Key Phase II Study Data for PD-1 Monoclonal Antibody in Hodgkin’s Lymphoma: Objective Response Rate Approaches 80%

On May 17, Innovent Biologics announced the results of the pivotal ORIENT-1 study evaluating sintilimab (IBI308), a PD-1 monoclonal antibody, for the treatment of relapsed/refractory Hodgkin’s lymphoma. ORIENT-1 is a multicenter, Phase II study assessing the efficacy and safety of sintilimab in patients with relapsed or refractory classical Hodgkin’s lymphoma (cHL). The study enrolled a total of 96 patients with relapsed or refractory cHL, making it the largest study of its kind in China to date in terms of patient enrollment for this indication.

Following an evaluation of 24-week clinical data from 96 patients, the Independent Radiology Review Committee (IRRC) determined that the objective response rate (ORR) was 79.2% and the disease control rate (DCR) was 97.9%, thereby meeting the prespecified statistical endpoints. Subgroup analyses based on various criteria consistently demonstrated similar objective response rates. The median duration of response had not been reached, with the vast majority of patients maintaining ongoing disease response. No unexpected safety issues were identified during the study, and no deaths occurred. The safety profile of sintilimab was comparable to that of similar international products.

3

Treatment of Lung Cancer: Two New Drugs from Merck KGaA Achieve Excellent Results

Merck KGaA will present multiple abstracts at this year’s ASCO Annual Meeting, with significant attention drawn to two of its investigational new drugs. The first is tepotinib, a c-Met receptor tyrosine kinase inhibitor. In a Phase 2 clinical trial, tepotinib achieved a confirmed partial response (cPR) rate of 60% in patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations, while the disease control rate reached 20%.

Another new drug drawing attention is M7824, an investigational bifunctional immunotherapy that simultaneously targets the PD-L1 and TGF-β pathways, with the potential to reactivate and restore the body’s antitumor immune response, thereby controlling tumor growth. This innovative therapy has demonstrated favorable outcomes in patients with non-small cell lung cancer (NSCLC): among those with PD-L1-positive tumors (PD-L1 expression ≥1%), the overall response rate (ORR) to this new drug reached 40.7%. In patients with high PD-L1 expression (PD-L1 expression ≥80%), the ORR for M7824 was as high as 71.4%.

4

Phase 3 Clinical Trials Show Promising Results; Bayer’s Anticancer Drug Poised to Become a New First-Line Therapy

Desmoid tumors are a rare type of tumor that can cause pain, loss of mobility, or intestinal obstruction, among other issues; however, there is currently no standard treatment for this condition. Sorafenib, an oral VEGFR2/PDGFRB/RAF inhibitor developed by Bayer, was evaluated in a Phase 3 study. Researchers found that 87% of patients in the sorafenib group achieved one-year progression-free survival (PFS), compared to only 43% in the control group. Furthermore, the median PFS was 9.4 months in the control group, whereas it had not been reached in the treatment group (HR = 0.14, 95% CI: 0.06–0.33, p < 0.0001). The researchers indicated that this new drug has the potential to become a first-line therapy for certain patients with desmoid tumors.

5

3-Fold PFS! Significant Phase 3 Efficacy of New Drug for Head and Neck Cancer

Nimotuzumab is an EGFR inhibitor with promising potential for the treatment of head and neck cancer. Its efficacy was confirmed in a Phase 3 clinical trial that enrolled a total of 536 patients, who were evenly randomized into two treatment arms: one receiving radiotherapy and cisplatin (CRT group) and the other receiving additional nimotuzumab (NCRT group). The study demonstrated that the median progression-free survival (PFS) was 60.3 months (95% CI: 29.4–NA) in the NCRT group, compared to only 21 months (95% CI: 15.1–NA) in the CRT group. The proportion of patients achieving two-year PFS was also higher in the NCRT group (58.9% vs. 49.5%; HR = 0.74; 95% CI: 0.56–0.95; p = 0.022). These results suggest that the combination therapy adding nimotuzumab holds promise as a new treatment option for locally advanced squamous cell carcinoma of the head and neck.

Research NewsResearch Updates[ NO.17 2018 ]

1

Latest Advances in Professor Dennis Lo’s Research on Early Screening for Nasopharyngeal Carcinoma

On May 15, a research team led by Professor Dennis Lo of The Chinese University of Hong Kong published the latest findings demonstrating that cell-free DNA (cfDNA) sequencing targeting Epstein-Barr virus (EBV) can identify individuals potentially suffering from nasopharyngeal carcinoma. The related study has been published in the latest issue of PNAS. This study improves upon Professor Lo’s previously reported detection method, which used PCR to detect EBV DNA for referring asymptomatic individuals for further testing. It is reported that the research team has partnered with Grail, a cancer diagnostics startup, and plans to commercialize this test within the year.

2

20 Genes Associated with Sunburn That Determine the Risk of Developing Skin Cancer

According to a recent study, certain genes can determine which individuals are at higher risk of sunburn, potentially influencing their subsequent risk of developing skin cancer. By analyzing the genomes of 180,000 individuals of European ancestry from the United Kingdom, Australia, the Netherlands, and the United States, researchers identified 20 sunburn-associated genes, eight of which had already been demonstrated in previous studies to be linked to skin cancer.

Other NewsOther Updates[ NO.17 2018 ]

1

23andMe Sues Ancestry for Infringement of Ancestry Analysis Algorithm

On May 11 (U.S. time), 23andMe filed a lawsuit against its competitor Ancestry in the U.S. District Court for the Northern District of California, alleging that Ancestry infringed upon 23andMe’s patents for ancestry analysis algorithms and engaged in improper marketing practices. Additionally, 23andMe sought court orders to cancel Ancestry’s “ancestry” trademark registrations.

(Translational Medicine Network 360zhyx.com)