Nichole Tucker

An Orphan Drug Designation had been granted by the FDA to the CD40 antagonistic monoclonal antibody, APX005M for the treatment esophageal and gastroesophageal junction cancer, as well as for the treatment of patients with pancreatic cancer.

The FDA granted approval to the immune checkpoint inhibitor pembrolizumab as treatment of patients with relapsed or refractory classic Hodgkin lymphoma.

A rolling submission of a New Drug Application has been initiated for pacritinib, seeking FDA approval for the drug as treatment of patients with myelofibrosis with severe thrombocytopenia.

Across subsets of patients with thyroid cancer, an interesting collection of research was shared with oncologists during the 2020 European Society of Medical Oncology Virtual Congress, demonstrating improvement in outcomes for patients with thyroid cancers with newer and established approved regimens.

During a presentation at the National Comprehensive Cancer Institute 2020 Virtual Congress: Hematologic Malignancies, Shaji K. Kumar, MD, explained that each case of multiple myeloma requires a long-term strategy that starts with a strong approach in the frontline setting.

Breast cancer data reported during the 2020 European Society Medical Oncology Virtual Congress revealed major advances in the treatment paradigm. The agents included in these trials challenged that standard-of-care.

Palbociclib in combination with standard endocrine therapy did not improve invasive disease-free survival in patients with hormone receptor-positive, HER2-negative early breast cancer who have residual invasive disease after completing neoadjuvant chemotherapy, missing the primary end point of the phase 3 PENELOPE-B trial.

Multiple agents are now challenging chemotherapy as the golden standard in the front-line setting of advanced non–small cell lung cancer.

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.

The FDA granted Orphan Drug designation to the humanized anti-claudin18.2 autologous chimeric antigen receptor T-cell agent, CT041, for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma.

In an interview with Targeted Oncology following a virtual presentation for the ISGIO 2020, Yelena Janjigian, MD, provided an overview of the role of HER2-targeted therapies in advanced gastric cancer. She also explained the importance of biomarker testing in this space.

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.

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.

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

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.

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.

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.

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.

In season 1, episode 3 of Targeted Talks, the importance of precision medicine in breast cancer, and how that vitally differs in community oncology compared with academic settings, is the topic of discussion.

The FDA has granted a Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express the protein DKK1, following disease progression on or after prior treatment with fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal receptor growth factor/neu-targeted therapy.

The FDA accepted a supplemental New Drug Application for crizotinib and granted it a Priority Review as treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is positive for an ALK alteration.

A Biologics License Application was submitted to the FDA for loncastuximab tesirine, an antibody-drug conjugate, as treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

The presence of hypothyroidism caused by treatment with immunotherapy correlated with improvement in overall survival among patients with non–small cell lung cancer, suggesting that thyroid toxicity may be a predictor of response to immunotherapy in this patient population.

Preliminary activity was observed in an unselected group of patients with miscellaneous soft tissue sarcoma treated with trabectedin in combination with durvalumab in the phase 1b TRAMUNE trial. The results presented during the 2020 European Society of Medical Oncology Virtual Congress demonstrate the feasibility of utilizing this combination in soft tissue sarcoma.

Patients with advanced clear cell renal cell carcinoma treated with cabozantinib in combination with atezolizumab in the phase 1b COSMIC-021 study, had promising clinical activity, according to results from the study presented during the 2020 European Society of Medical Oncology Virtual Congress.

Patients with medullary thyroid cancer harboring abberations in RET who were treated with pralsetinib across therapy lines exhibited potent and durable clinical activity, according to results presented at the ESMO Virtual Congress 2020 from the phase 1/2 ARROW clinical trial.

Patient-reported outcomes data showed the quality of life was not reduced with niraparib in patients with ovarian, primary peritoneal, or fallopian tube cancer compared with placebo.

The use of durvalumab as treatment of patients with resectable non–small cell lung cancer in the neoadjuvant setting showed preliminary promise with a satisfactory complete surgical resection rate, according to the phase 2 IFCT-1601 IONESC study.

Enzastaurin is on track to serve an unmet medical need in the treatment landscape of glioblastoma. Neuro-oncologists are waiting on the launch of an important clinical trial to further demonstrate the efficacy of the drug.