GI CANCERS

The combination of paclitaxel and GSK2636771 showed encouraging antitumor activity and a manageable toxicity profile and in patients with PTEN-deficient advanced gastric cancer who progressed after first line chemotherapy.

Final overall survival and long-term safety results of the phase 3 NETTER-1 trial were presented during the World Congress on Gastrointestinal Cancer 2021.

Treatment with avapritinib in Chinese patients with PDGFRA D842V-mutant gastrointestinal stromal tumors revealed promising clinical benefit, according to a bridging study of the NAVIGATOR trial.

Pembrolizumab monotherapy demonstrated improvement in health-related quality of life in patients with previously treated metastatic microsatellite instability-high/ mismatch repair deficient advanced noncolorectal solid tumors, with the biggest improvements seen in those who achieved a complete remission or partial remission.

Dostarlimab achieved durable antitumor responses in patients with non-endometrial mismatch repair–deficient solid tumors treated in an expansion cohort of the phase 1 GARNET trial, according to interim findings presented during the ESMO World Congress on Gastrointestinal Cancer.

The FDA has accepted the filing of a new drug application for surufatinib to be indicated as treatment of patients with advanced neuroendocrine tumors. The FDA set a Prescription Drug User Fee Act target action date of April 30, 2022.

Patients with unresectable hepatocellular carcinoma with Child-Pugh class B liver function experienced a similar tumor size reduction as their Child-Pugh class A counterparts, all treated with lenvatinib, according to a post-hoc analysis of the phase 3 REFLECT study.

The phase 3 LEAP-015 trial is actively looking at the efficacy and safety of the combination of pembrolizumab, lenvatinib, and chemotherapy in the first-line setting for patients with advanced gastroesophageal adenocarcinoma compared with chemotherapy alone.

The phase 3 KRYSTAL-10 trial continues to look at the combination of adagrasib and cetuximab in patients with previously treated advanced colorectal cancer and a KRAS G12C mutation in their tumor.

Treatment with nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with resected pancreatic cancer showed positive 5-year overall survival outcomes that were consistent with the primary analysis of the phase 3 APACT clinical trial as well as a post hoc analysis.

Increasing the dose of the primary treatment modality for anal squamous cell carcinoma, chemoradiotherapy, may further improve efficacy for patients with effective organ preservation and disease control.

The FDA has granted orphan drug designation to devimistat for the treatment of patients with biliary cancer,

The combination of cabozantinib and atezolizumab demonstrated improvement in both progression-free and overall survival compared with sorafenib, in patients with untreated advanced hepatocellular carcinoma.

The FDA’s Oncologic Drug Advisory Committee voted 13 to 4 for the deferral of the FDA approval of retifanlimab for the treatment of patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy, pending more research.

Relacorilant administered in combination with nab-paclitaxel elicited responses in patients with metastatic pancreatic cancer, leading to the halting of enrollment in the phase 2 RELIANT trial.

Sintilimab injection in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival as frontline treatment of patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

The FDA has granted an orphan drug designation to gunagratinib (ICP-192) for the treatment of cholangiocarcinoma.

An FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.

Pimitespib, a heat shock protein 90 inhibitor doubled the progression-free survival and prolonged the overall survival compared with placebo in patients with advanced gastrointestinal stromal tumor that is refractory to imatinib, sunitinib, and regorafenib, according to results from the phase 3 CHAPTER-GIST-301 trial.

The combination of regorafenib and avelumab showed modest anti-tumor activity and survival rates in patients with heavily-pretreated biliary tract solid tumors.

Data from the phase 2 NIFTY trial demonstrated that a combination with liposomal irinotecan significantly improved survival in patients with metastatic biliary tract cancer.

Patients with advanced gastrointestinal stromal tumor after receiving fourth-line therapy had extended progression-free survival when given an intra-patient dose escalation of ripretinib to 150 mg twice a day following progression.

The FDA has granted accelerated approval to the oral FGFR1-3 selective inhibitor, infigratinib for the treatment of patients with cholangiocarcinoma who harbor an FGFR2 gene fusion or rearrangement.

Treatment options are available for patients with late-stage gastric cancer in the early- to late-line settings.

The FDA granted approval to adjuvant nivolumab as treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy.