Global Oncology

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adults with unresectable malignant pleural mesothelioma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab for use in 2 advanced cancers: non–small cell lung cancer and basal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma with PD-L1 positivity.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of nivolumab and ipilimumab as an option for patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following fluoropyrimidine-based combination therapy.

The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.

Ullas Batra, MBBS, MD, DM, discusses the durability of targeted therapy in advanced NSCLC and the movement of targeted therapy and immunotherapy into earlier stages of disease.

Acalabrutinib elicited early antitumor activity with acceptable tolerability in a population of Japanese patients with relapsed/refractory B-cell malignancies.

Effective early detection and optimal management are critical in preventing high-grade interstitial lung disease, a treatment-related adverse effect of fam-trastuzumab deruxtecan-nxki in patients with HER2-positive metastatic breast cancer.

Distinct gene signatures, with the exception of estrogen receptor signaling and BRCAness, are associated with pathologic complete response and invasive disease-free survival, in patients with HER2-positive breast cancer who received trastuzumab and pertuzumab alone or in combination with paclitaxel.

Approximately 30% of breast cancer tumors can covert from, or to, HER2-low status, underscoring the need to retest for HER2 expression upon relapse.

Although administering trastuzumab for 1 year in patients with HER2-positive early breast cancer continues to be standard, a 9-week de-escalation approach may be a reasonable option in a large proportion of the real-world HER2-positive population.

Ribociclib plus endocrine therapy improved overall survival and post-progression outcomes in pre- or postmenopausal patients with hormone receptor–positive, HER2-negative advanced breast cancer irrespective of age.

Treatment with atezolizumab plus carboplatin demonstrated early clinical activity in patients with metastatic invasive lobular breast cancer, with slight trends toward increased clinical benefit in patients with triple-negative ILC and responders with higher PD-L1 expression, according to initial findings of the non-randomized phase 2 GELATO trial.

Post-treatment care for breast cancer survivors must be personalized to address each survivor’s unique experiences.

The European Commission has approved atezolizumab for use as a frontline treatment in patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and do not harbor EGFR or ALK aberrations.

The European Commission has approved enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

Centrally stratified risk-adapted clinical trials in patients with newly diagnosed multiple myeloma were shown to be feasible, addressing an unmet need and providing the opportunity for rapid clinical development of novel therapies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended osimertinib for the adjuvant treatment of adult patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

Current breast cancer screening practices in the Caribbean exclude the majority of the younger patient population, thereby leaving many cases of breast cancer undiagnosed.

The European Medicines Agency has validated a Type II Variation Marketing Authorization Application to Karyopharm Therapeutics Inc. for selinexor in combination with bortezomib and low-dose dexamethasone as a treatment for adult patients with multiple myeloma who have received at least 1 prior therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant

The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.

The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.

The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.

The National Institute for Health and Care Excellence has published draft guidance that recommends fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer following 2 or more anti-HER2 therapies.

Tocilizumab may represent a potential treatment option with double action against cytokine storm due to COVID-19 in a subset of patients with active multiple myeloma and severe infection with the virus.

Health Canada has approved daratumumab injection, a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone in the treatment of patients with newly diagnosed light chain amyloidosis.

The European Commission has approved isatuximab for use in combination with carfilzomib and dexamethasone in the treatment of patients with relapsed multiple myeloma who have received at least 1 previous therapy.

The European Commission has approved the combination of nivolumab and cabozantinib as a frontline treatment in patients with advanced renal cell carcinoma.