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In Brief This Week: Janssen, Amgen, Daiichi Sankyo, AstraZeneca, Interpace Biosciences

NEW YORK – Janssen presented data this week at the International Association for the Study of Lung Cancer's World Conference on Lung Cancer from the Phase I CHRYSALIS trial of its EGFR-MET bispecific antibody amivantamab in EGFR exon 20-mutated metastatic or unresectable non-small cell lung cancer. Among 81 patients previously treated with platinum-based chemotherapy, the overall response rate with amivantamab was 40 percent and the duration of response was 11.1 months. The median progression-free survival was 8.3 months and the median overall survival was 22.8 months. Last month, Janssen submitted a biologics license application for amivantamab in NSCLC patients with EGFR exon 20 insertion mutations to the US Food and Drug Administration and European Medicines Agency


Amgen reported detailed results this week from the Phase II CodeBreak-100 trial, in which the company is investigating the activity of sotorasib in KRAS G12C-mutated advanced non-small cell lung cancer. In the 126-patient trial, the participants had progressed on platinum-based chemotherapy or anti-PD-1/PD-L1 inhibitors, or both. As of the Dec. 2 data cutoff, the objective response rate was 37 percent and the disease control rate was 81 percent, with three patients achieving complete responses. Median duration of response was 10 months, while median progression-free survival was 6.8 months, consistent with earlier Phase I results. The drug caused mostly mild-to-moderate adverse events. In the study, researchers also conducted exploratory biomarker analysis, and reported that patients with negative- or low-PD-L1 expression in their tumors and STK11 mutations also responded to sotorasib. Patients with these tumor biomarker profiles tend not to respond well to immunotherapy. 

The company will present these data at the International Association for the Study of Lung Cancer's World Conference on Lung Cancer, which starts on Friday. Amgen also included data from CodeBreak-100 in the new drug application it filed in December with the US Food and Drug Administration for sotorasib in KRAS G12C-mutated NSCLC. Amgen has also filed for marketing authorization for sotorasib in the same indication in Europe, Brazil, Canada, Australia, and the UK. 


At the International Association for the Study of Lung Cancer's World Conference on Lung Cancer, Daiichi Sankyo and AstraZeneca presented data this week from two studies exploring the activity of their investigational therapy datopotamab deruxtecan and trastuzumab deruxtecan (Enhertu) in non-small cell lung cancer.  

The Phase I trial of datopotamab deruxtecan, called TROPION-PanTumor01, has enrolled 159 patients with advanced or metastatic NSCLC. In the study, the objective response rate ranged from 21 percent to 25 percent and progression-free survival ranged from 4.3 months to 8.2 months, depending on dosage.

The data from the Phase II DESTINY-Lung01 trial focused on trastuzumab deruxtecan's activity in patients with HER2-overexpressing metastatic NSCLC. The interim analysis showed an objective response rate of 24.5 percent and a median progression-free survival of 5.4 months. In this study, the companies are also studying the drug's efficacy in metastatic NSCLC patients with HER2-mutated tumors, and presented data from this cohort last year. In the US, trastuzumab deruxtecan is already approved for advanced or metastatic, HER2-positive, gastric or gastroesophageal junction cancer patients who have previously received a trastuzumab (Genentech's Herceptin)-based treatment; and for unresectable or metastatic, HER2-positive breast cancer patients after they've received at least two other HER2-directed regimens for metastatic disease.  


Interpace Biosciences said this week that its diagnostics group has signed a contract with Blue Cross Blue Shield of Florida. Interpace's ThyGeNext and ThyraMir tests for indeterminate thyroid nodules will be adjudicated as in-network lab services for BCBS of Florida's 5 million members, effective Jan 1. 


Aspira Women's Health this week announced that it has become a participating laboratory network provider for Highmark health insurance products in Pennsylvania and West Virginia. Highmark, an independent licensee of the BlueCross BlueShield Association, operates health insurance plans in Pennsylvania, Delaware, and West Virginia that serve more than 4.4 million members. 

Aspira, formerly known as Vermillion, markets the OVA1 and OVERA tests, which detect the risk of ovarian malignancy in women with adnexal masses. In spite of a year impacted by the COVID-19 pandemic, Aspira said it increased the total in-network access for its tests to more than 154 million individuals. 


Zymeworks said this week that it has begun enrolling patients into an expansion cohort of its ongoing Phase I trial evaluating its HER2-targeted antibody-drug conjugate, ZW49, as a treatment for patients with a variety of heavily pretreated HER2-positive cancers. Based on the antitumor activity observed in the trial's initial dose-escalation portion, the dose-expansion portion will include three cancer-specific cohorts: One cohort will enroll patients with HER2-positive breast cancer, one will enroll patients with HER2-positive gastroesophageal adenocarcinoma, and the third will be a basket cohort enrolling patients with a variety of other HER2-positive tumor types.


Latvia-based Smartomica said this week that its next-generation sequencing and artificial intelligence-based technologies will be used to help guide personalized treatment decisions within the Pediatric Cancer Initiative, a collaboration between the Latvian Biomedical Research and Study Center, Children's University Hospital, and Mikrotik. The genetic information gleaned through Smartomica's testing capabilities will be used to identify druggable targets and to better characterize the biology of pediatric cancers.


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.