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Topline results from the phase 2 CodeBreaK 100 clinical trial were consistent with phase 1 data, withthe KRAS inhibitor sotorasib having achieved a satisfactory objective response rate when administered as treatment of patients with KRAS G12C–mutant non–small cell lung cancer, who had failed a median of 2 prior lines of anti-cancer therapies, which could include immunotherapy and/or chemotherapy.

Despite concerns about treatment-related immunosuppression, a report out of Spain suggests SARS-CoV-2 precautions can offset risk for patients with diffuse large B-cell lymphoma.

With the number of targets in gastrointestinal cancer growing, particularly KRAS in colorectal cancer and tumor mutational burden across all gastrointestinal tumors, Andrea Cercek, MD, sought to provide an overview of current and emerging targets during the 17th Annual Meeting of the International Society of Gastrointestinal Oncology.

Selpercatinib-related hypersensitivity reactions occurred infrequently in patients with RET fusion-positive non–small cell lung cancer, with more cases reported in patients previously treated with an immune checkpoint inhibitor, but reactions were deemed manageable with recommended guidance and supportive care.

Laura Goff, MD, discussed the combination of atezolizumab plus bevacizumab in relation to its effect on the treatment paradigm of hepatocellular carcinoma during a presentation at the 17th Annual Meeting of the International Society of Gastrointestinal Oncology.

In an interview with Targeted Oncology following ISGIO 2020, Elena Chiorean, MD, oncologist, discussed universal genetic testing at the time of diagnosis for patients with pancreatic cancer, a topic she argued on during an ISGIO medical crossfire. She also explained the challenges with execute germline testing setting.

The FDA granted a Breakthrough Therapy designation to IMGN632 as treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasms.

Immunotherapy has demonstrated significant benefits in recent large trials, reaching new survival benchmarks for upper gastrointestinal cancers across various settings of disease, according to Jaffer A. Ajani, MD.

Although HER2 positivity has been identified as a predictive factor of response to chemotherapy, it remains controversial considering that responses to chemotherapy can vary in patients with certain disease characteristics.

The FDA approved nivolumab in combination with ipilimumab for the frontline treatment of adult patients with unresectable malignant pleural mesothelioma.

The “switchable” chimeric antigen receptor T-cell therapy CLBR001 plus SWI019 received a Fast Track designation for patients with B-cell malignancies such as non-Hodgkins lymphoma and chronic lymphocytic leukemia, according to a press release from Scripps Research.

Here is a look back at the FDA happenings from the month of September 2020.

Targeted Oncology reviews trending news online for the week of October 2, 2020, including updates in oncology and the latest conference coverage.

The FDA issued a Complete Response Letter to remestemcel-L for the treatment of pediatric patients with steroid-refractory acute-graft-versus-host disease.

In an interview with Targeted Oncology, Anthony P. Conley, MD, discussed findings from an analysis of the efficacy and safety of entrectinib in patients with non-small cell lung cancer harboring a ROS1 or TRK fusion.

Due to the high prevalence of KRAS-mutant colorectal cancer and the fact that many different KRAS variants are found in these tumors, developing treatment for patients with KRAS-mutant colorectal cancer is an area of unmet medical need

In a phase 3 trial, atezolizumab demonstrated a significantly longer overall survival in patients with non-small cell lung cancer who had high PD-L1 expression regardless of histologic type compared with platinum-based chemotherapy.

During a Targeted Oncology Case Based Peer Perspectives event, Ghasson K. Abou-Alfa, MD, reviewed the case of a 77-year old woman with hepatocellular carcinoma.

Afatinib monotherapy demonstrated clinical activity in Asian and non-Asian patients with non–small cell lung cancer who harbored uncommon EGFR mutations, according to findings from a subanalysis of the afatinib uncommon mutation database.

In an interview with Targeted Oncology, Ghassan K. Abou-Alfa, MD, discussed the evolution of the liver cancer treatment landscape and recognizes some of most important advances in the field during Liver Cancer Awareness Month.

In an interview with Targeted Oncology, Daniel A. Vorobiof, MD, discussed the evolution of the breast cancer treatment landscape and the emerging role of genomic testing in this space during Breast Cancer Awareness Month.

A New Drug Application for pacritinib is planned to be submitted for potential accelerated approval from the FDA for the treatment of patients with myelofibrosis and severe thrombocytopenia.

Arturo Loaiza-Bonilla, MD, MSEd, FACP ascended to the presidency of the Pennsylvania Society of Oncology, albeit virtually, during the society’s Annual Scientific Conference held via ZOOM on September 25.

A review was conducted to understand how precision medicine strategies can be successfully implemented in diffuse large B-cell lymphoma

Atezolizumab in combination with bevacizumab, carboplatin, and paclitaxel demonstrated continued progression-free survival and overall survival benefit at 20 months of follow-up compared with chemotherapy alone in patients with chemotherapy-naïve metastatic nonsquamous non–small cell lung cancer who harbor an EGFR mutation, IMpower150 study results show.

Relugolix demonstrated a similar rate of castration resistance-free survival compared with the current standard of care leuprolide acetate as treatment of patients with metastatic prostate cancer.

A Fast Track designation was granted by the FDA to eganelisib in combination with an immune checkpoint inhibitor and chemotherapy for the first-line treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer.

CLR 131, a phospholipid ether molecule, is showing promising disease control in an ongoing phase 2 study as treatment of patients with relapsed or refractory lymphoplasmacytic lymphoma and Waldenström macroglobulinemia, according to initial study results.

Camrelizumab plus apatinib demonstrated a high objective response rate and disease-control rate, as well as durable responses and long survival as treatment of patients with advanced hepatocellular carcinoma, according to the results from the phase 2 RESCUE clinical trial.

The sintilimab injection in combination with IBI305, a biosimilar to bevacizumab, improved overall survival as well as progression-free survival compared with sorafenib as front-line treatment of patients with advanced hepatocellular carcinoma, meeting the predefined primary end point of the phase 3 ORIENT-32 clinical trial.