Lisa Astor

Findings from the OCTOPUS Consortium of trial data have indicated that obese patients with colorectal cancer have a poorer survival from adjuvant chemotherapy treatment due to reduced treatment dose and average cumulative relative dose.

A propensity score matching analysis presented in a poster during the 2021 World Congress on Gastrointestinal Cancer demonstrated that lenvatinib was superior to sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma.

An excerpt from the Targeted Talks highlights the interest in PD-1/PD-L1 and CTLA-4 antibodies, their mechanisms of action, and the potential they bring to the immunotherapy field.

Newer immunotherapy approaches continue to be explored to treat patients with relapsed or refractory MCC after PD-1/ PD-L1 inhibition.

Research has suggested that neoadjuvant immunotherapy combinations are superior to adjuvant immunotherapy for patients with stage III melanoma.

Targeted therapy use in melanoma has been extended beyond just metastatic disease to now include adjuvant therapy for patients with resected stage III melanoma.

Naratuximab emtansine in combination with rituximab showed deep responses and a duration of response that was not reached in patients with relapsed or refractory diffuse large B-cell lymphoma, according to findings from a phase 2 trial presented during the EHA 2021 Virtual Congress.

Updated findings for belzutifan showed that with further follow-up, the hypoxia-inducible factor-2 alpha inhibitor continues to show significant clinical activity in patients with Von-Hippel Lindau–associated renal cell carcinoma treated in the frontline setting. Updated results from the phase 2 study.

Further follow up of lifileucel in patients with melanoma showed potentially follow progression on anti—PD-1 therapy.

Utilizing a de-escalation of treatment strategy, researchers found a high response and significant results among patients with HER2+ breast cancer.

Amivantamab in combination with lazertinib led to responses in more than a third of patients with EGFR-mutant non–small cell lung cancer who had progressed on treatment with osimertinib but had not received chemotherapy.

The FDA’s Oncologic Drugs Advisory Committee has voted 6 to 2 against the continued approval of pembrolizumab as indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 who experienced disease progression on or after 2 or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2-targeted therapy.

The FDA has granted a priority review to mobocertinib as a treatment for adult patients with EGFR exon 20 insertion–mutant metastatic non–small cell lung cancer, as detected by an FDA-approved test, and who have received prior platinum-based chemotherapy.

The triplet regimen of nivolumab, ipilimumab, and panitumumab has shown antitumor activity and a consistent safety profile in patients with previously treated metastatic colorectal cancer that is microsatellite stable and KRAS, NRAS, and BRAF wild type, according to findings from the phase 2 LCCC1632 study.

The FDA has been leading an industry-wide evaluation of accelerated approvals of oncology drugs for which the clinical benefit was not verified in confirmatory trials.

In the phase 2 C-144-01 trial, patients had durable responses to treatment with the tumor-infiltrating lymphocyte lifileucel after more than 28 months of follow-up.

The FDA has accepted a biologics license application and granted it a priority review for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Half of all patients with hepatocellular carcinoma treated with the combination of regorafenib and nivolumab following progression on 2 lines of chemotherapy achieved disease control, according to initial results from a phase 2 proof-of-concept trial.

The FDA has approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma after 4 or more prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

In a single-arm study, 100% of patients treated with sintilimab plus stereotactic body radiotherapy who had oligometastases of hepatocellular carcinoma achieved disease control and were alive and progression free at 6 months.

The FDA has approved pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy for the treatment of patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma who are not eligible for surgical resection or definitive chemoradiation.

Olaparib maintenance continues to show clinical activity in platinum-sensitive ovarian cancer, including in patients with somatic BRCA mutations and non-BRCA homologous recombination repair mutations.

Compared with standard-of-care chemotherapy, treatment with the PARP inhibitor rucaparib led to a significant prolongation of progression-free survival and improved duration of response in patients with BRCA-mutated advanced, relapsed ovarian cancer, according to primary results from the phase 3 ARIEL4 trial.

The FDA has approved TheraSphere yttrium-90 glass microspheres for the treatment of patients with unresectable hepatocellular carcinoma.

The FDA has granted CYNK-001, a natural killer cell therapy, with a fast track designation for the treatment of adult patients with recurrent glioblastoma multiforme, according to a press release from developer Celularity.

The FDA has granted an orphan drug designation to ARX788 for the treatment of patients with HER2-positive gastric cancer, according to a press release from developer Ambrx.

The novel, selective hypoxia-inducible factor-2 alpha inhibitor belzutifan was granted a priority review by the FDA for the treatment of patients with von Hippel-Lindau disease–associated renal cell carcinoma who do not require immediate surgery.

A phase 3 trial for cemiplimab monotherapy in comparison with chemotherapy in patients with recurrent or metastatic cervical cancer who previously received chemotherapy treatment is being stopped early due to a unanimous recommendation by the Independent Data Monitoring Committee due to positive overall survival results.

The FDA has issued a complete response letter to PharmaEssentia Corporation for the company’s biologics license application for ropeginterferon alfa-2b-njft as a potential treatment for patients with polycythemia vera.

The FDA has announced a meeting of the Oncologic Drugs Advisory Committee to review 6 accelerated approvals for immunotherapy agents where the clinical benefit was not verified in confirmatory trials. The ODAC meeting will be taking place April 27 through 29.