GI CANCERS

To help clinicians cope with an increasing number of geriatric patients with cancer, the Association of Community Cancer Centers is addressing this problem with a 2-pronged approach that focuses on the delivery of care and diagnostic assessment.

The FDA has granted Priority Review to the New Drug Application for ripretinib as treatment of patients with advanced gastrointestinal stromal tumors. This potential FDA approval has a Prescription Drug User Fee Act target action date of August 13, 2020, according to a press release from Deciphera Pharmaceuticals, Inc.<br /> &nbsp;

The FDA has extended the Prescription Drug User Fee Act date by 3 months for the new drug application of avapritinib from February 14, 2020, to May 14, 2020, the manufacturer, Blueprint Medicines Corporation, announced in a news release.&nbsp;The NDA was seeking accelerated approval for the kinase inhibitor for the treatment of adults with fourth-line gastrointestinal stromal tumors.

The incidence of colorectal cancer is rising among people who are below 50 years of age, the colonoscopy screening age as recommended by the United States Preventive Service Task Force of the National Cancer Institute. To date, there is no research that can explain the rise which has led physicians to deliberation on whether the recommended screening age for colonoscopies should be lowered or left as is. During a debate at the 2020 Gastrointestinal Cancers Symposium, Uri Ladabaum, MD, and David S. Weinberg, MD, MSc, presented their stances on the topic.

A new phase II study of trastuzumab and pertuzumab added to neoadjuvant chemoradiotherapy followed by surgery in patients with esophageal adenocarcinoma has found the combined regimen to be feasible and worthy of further study.

The HER2-targeted antibody-drug conjugate trastuzumab deruxtecan demonstrated promising activity and manageable safety profile in patients with HER2-positive gastric or gastroesophageal junction cancer, meeting the primary end point of the study, according to a press release.

The combination of regorafenib plus an oral fluoropyrimidine, TAS-102, as third-line treatment in patients with metastatic colorectal cancer, achieved a clinically meaningful disease control rate in the phase I dose-escalation trial REMETY, according to data presented at the 2020 Gastrointestinal Cancers Symposium.

Joseph Chao, MD, discusses the importance of assessing the microsatellite instability (MSI) status in patients with advanced gastric/gastroesophageal junction cancer based on findings from a comparative analysis of KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062.

In an interview with&nbsp;Targeted Oncology, Vincent Chung, MD, discussed the findings from the pilot trial evaluating the addition of dietary supplements to combination chemotherapy in patients with unresectable pancreatic cancer. He also highlighted the importance of these findings and the next steps necessary to evaluate the role of supplements in pancreatic cancer further.

Promising antitumor activity with durable responses were demonstrated with the combination of nivolumab and ramucirumab plus paclitaxel&nbsp;in a phase II study of patients with advanced gastric cancer, which wsa presented at the 2020 Gastrointestinal Cancers Symposium.&nbsp;Among patients treated with the combination, the objective response rate was 37.2%, and all responders had a partial response.

Overall survival was meaningfully improved with treatment of pembrolizumab in first and later lines for patients with&nbsp;advanced gastric/gastroesophageal junction cancer with a high number of PD-L1&ndash;expressing cells in the tumor, lymphocytes, and macrophages compared with chemotherapy.

A subset of patients with GI cancers harboring&nbsp;<em>NTRK</em>&nbsp;gene fusions had positive responses to selective TRK inhibition with larotrectinib, confirming efficacy of the agent in this group. The results of the confirmatory trial were recently reported the 2020 Gastrointestinal Cancers Symposium.

Hirva Mamdani, MD, explains the rationale for conducting a safety and efficacy study of durvalumab in patients following multimodality therapy for locally advanced esophageal and gastroesophageal junction adenocarcinoma.

A phase Ib/II clinical trial of the experimental anti-mitochondrial drug devimistat in combination with cisplatin and gemcitabine has been initiated in patients with biliary tract cancer, according to a press release from Rafael Pharmaceuticals, Inc. The company will collaborate with Michigan Medicine to proceed with the randomized multicenter clinical trial.

Integrating a geriatric assessment into the care of older adults who are receiving cancer treatment in communi&shy;ty oncology practices improves patient and caregiver satisfaction and encourages commu&shy;nication about aging-related concerns, accord&shy;ing to results of a clinical trial that enrolled 541 patients with advanced cancer.

The present and future benefits of telehealth in oncology can be observed through Tahoe For&shy;est Cancer Center and its affiliation with the UC Davis Cancer Center, use of other remote clinics, and participation in virtual tumor boards. Even though there are roadblocks to telehealth reaching more locations and more patients, the potential benefit warrants the time needed to get over those hurdles.

Aiwu Ruth He, MD, discusses the current role of immune checkpoint inhibitors in upper gastrointestinal and gastric cancers and which patients are most likely to benefit from the anti&ndash;PD-1 agents.

Infigratinib has been granted Fast Track Designation by the FDA for the treatment of cholangiocarcinoma in adult patients with first-line advanced or metastatic disease, according to a press release from QED Therapeutics, a subsidiary of BridgeBio Pharma, Inc, and developer of infigratinib.

In an interview with&nbsp;Targeted Oncology&nbsp;at the 2019 Ruesch Symposium, Fearon, professor, Weil Cornell Medicine, discussed his presentation on the CXCL-12 pathway, which can exclude T cells from pancreatic ductal adenocarcinoma. He also shared his opinion on how to advance the treatment landscape in the future.

The FDA granted approval to countless treatments across cancer types throughout 2019 until the end of the year, with a final approval on December 31^st&nbsp;for the first BRCA targeted therapy in pancreatic cancer. Following the excitement for a new year of further advances,&nbsp;Targeted Oncology&nbsp;followers on Twitter shared their thoughts on some of the most impactful FDA approvals in 2019.

Individuals with obesity who were diagnosed with locally advanced or metastatic clear cell renal cell carcinoma achieved longer overall survival than patients of normal weight in select groups of an independent cohort study, which evaluated overall survival and the transcriptomic differences in the primary tumor and peritumoral adipose tissue in adult patients with metastatic clear cell renal cell carcinoma.

Results from a phase II prospective trial indicate that fluorouracil-, leucovorin-, irinotecan-, and oxaliplatin-based treatment and imaging-based biomarkers for borderline resectable pancreatic ductal adenocarcinoma achieved a resection rate of 45% and a median overall survival of 2 years.<br /> &nbsp;

In a 7-to-5 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee recommended the PARP inhibitor olaparib as first-line maintenance therapy for patients with germline&nbsp;BRCA-mutated metastatic pancreatic cancer whose disease did not progress after first-line treatment with platinum-based chemotherapy, AstraZeneca and MSD, Inc. reported in a press release.<br /> &nbsp;

New results from the KEYNOTE-164 trial have shown that patients with previously treated microsatellite instability-high DNA mismatch repair advanced or metastatic colorectal cancer who received pembrolizumab responded well to the drug.

The FDA Oncologic Drugs Advisory Committee has announced a hearing to discuss a supplemental new drug application for olaparib tablets&nbsp;<a>for the maintenance treatment of adult patients with deleterious or suspected deleterious germline&nbsp;<em>BRCA-</em>mutant metastatic pancreatic adenocarcinoma</a>&nbsp;who have not progressed on first-line platinum-based chemotherapy.

Timil Patel, MD, discusses how to sequence therapies in a patient with rectal cancer with a single lung nodule.

In November 2019, the FDA approved a number of treatments, including acalabrutinib for the treatment of chronic lymphocytic leukemia and small lymphocytic leukemia, as well as zanubrutinib for the treatment of mantle cell lymphoma. A biosimilar for pegfilgrastim was also approved under indications.

In patients whose solid<strong> </strong>tumors harbor a mutation in <em>KRAS </em>G12C, therapy with MRTX849 has produced promising responses and acceptable toxicity across 3 tumors types, according to data presented at the 2019 American Association for Cancer Research&ndash;National Cancer Institute&ndash;European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics.

The FDA has granted a priority review designation to a New Drug Application for pemigatinib, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, according to a press release from Incyte.

Surufatinib has been granted FDA Orphan Drug Designation for the treatment of pancreatic neuroendocrine tumors, according to a press release from Hutchison China MediTech Limited.