Gina Columbus

Suresh A. Ramalingam, MD, discusses recent updates in EGFR-mutant non–small cell lung cancer and the next steps for osimertinib and other agents in this patient population.

A new drug application will be submitted to the FDA under accelerated approval status for lurbinectedin monotherapy for the second-line treatment of patients with small cell lung cancer, according to PharmaMar, the developer of the marine-derived agent.

The FDA has approved fedratinib (Inrebic) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis.

Treatment with the cryopreserved autologous tumor-infiltrating lymphocyte therapy lifileucel (LN-144) elicited a 38% objective response rate in heavily pretreated patients with metastatic melanoma.

The FDA has granted an accelerated approval to entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor a NTRK fusion, and has also approved the agent for the treatment of adults with ROS1-positive, metastatic non–small cell lung cancer.

The FDA has granted a breakthrough therapy designation to acalabrutinib (Calquence) for the treatment of patients with chronic lymphocytic leukemia.

Peter Voorhees, MD, discusses the recent data with triplet regimens in late relapsed multiple myeloma and other novel agents shaking up the paradigm.

The European Commission has expanded the approval of ibrutinib to include use in combination with obinutuzumab for adult patients with previously untreated chronic lymphocytic leukemia, and also in combination with rituximab for the treatment of adult patients with Waldenström macroglobulinemia.

Ripretinib (DCC-2618) improved progression-free survival compared with placebo in patients with fourth-line and fourth-line plus advanced gastrointestinal stromal tumors, according to topline findings of the phase III INVICTUS study (NCT03353753).

The FDA has granted a priority review designation to a new drug application for avapritinib for the treatment of adult patients with PDGFRA exon 18–mutant gastrointestinal stromal tumors, regardless of prior therapy, as well as for patients with GIST in the fourth-line setting.

Olaparib demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared with enzalutamide or abiraterone acetate in patients with metastatic castration-resistant prostate cancer who harbor a homologous recombination repair gene mutation and have progressed on prior therapy with either androgen receptor inhibitor, meeting the primary endpoint of the phase III PROfound trial.

Cell-free DNA-based detection of microsatellite instability status was found to be highly concordant with tissue-based MSI testing.

The FDA has approved pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor that is associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

Treatment with afatinib (Gilotrif) followed by osimertinib (Tagrisso) led to a median overall survival of 41.3 months and a 2-year OS rate of 80% in patients with EGFR T790M-positive non–small cell lung cancer in a real-world setting.

The FDA granted a breakthrough therapy designation to the combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) for the treatment of patients with previously untreated unresectable or metastatic melanoma.

Konstantinos Arnaoutakis, MD, discusses pivotal updates in stage III disease, immunotherapy combinations in advanced non–small cell lung cancer, and advances in EGFR- and ALK-mutated lung cancer.

The FDA has approved pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (combined positive score ≥10) as determined by an FDA-approved test, with disease progression after ≥1 prior lines of systemic therapy.

The FDA has approved darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

Abemaciclib plus fulvestrant improved overall survival in patients with hormone receptor–positive, HER2-negative breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the triplet regimen of atezolizumab (Tecentriq), carboplatin, and nab-paclitaxel (Abraxane) for the first-line treatment of patients with advanced, nonsquamous non–small cell lung cancer who do not have EGFR or ALK molecular aberrations.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of atezolizumab in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.

Pembrolizumab in combination with chemotherapy led to a statistically significant improvement in pathological complete response rates compared with placebo plus chemotherapy in the neoadjuvant phase of a neoadjuvant/adjuvant treatment regimen in patients with triple-negative breast cancer, meeting one of the dual primary endpoints of the phase III KEYNOTE-522 trial.

With the arrival of immunotherapy to the small cell lung cancer armamentarium, combination approaches with targeted therapies are now in the pipeline to stimulate further clinical activity, such as adding PARP or CHK1 inhibitors.

Checkpoint inhibitors in the neoadjuvant setting, as consolidation post-chemoradiation, or in combination with concurrent chemoradiation, are all strategies actively being pursued in the locally advanced non–small cell lung cancer setting.

The future generation of agents in lung cancer should be evaluated in improved predictive biomarker-driven trials to identify patients who are most likely to benefit or have detriment for both TKIs and checkpoint inhibitors.

There is a growing need to share information across research settings and the community, with the rapid introduction of new biomarkers, cancer detection strategies, immunotherapies, and targeted therapies. This synchronization of system biology tool datasets could help create a new digital ecosystem focused on precision medicine.

The combination of nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) was superior in overall survival compared with chemotherapy for the first-line treatment of patients with non–small cell lung cancer whose tumors express PD-L1 ≥1%, meeting the co-primary endpoint of part 1a of the phase III CheckMate-227 trial.

The FDA has approved PF-05280586, a biosimilar for rituximab, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia in combination with chemotherapy.

The FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma that is not amenable to locoregional therapy.

The FDA has updated the label for durvalumab for patients with unresectable, stage III non–small cell lung cancer whose disease has not progressed following concurrent platinum-based chemoradiation to include overall survival data from the phase III PACIFIC trial.