Gina Columbus

The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) did not improve overall survival versus placebo as a maintenance therapy for patients with extensive-stage small cell lung cancer without disease progression following frontline platinum-based chemotherapy.

Avelumab (Bavencio) alone or in combination with pegylated liposomal doxorubicin did not induce a statistically significant improvement in overall survival or progression-free survival versus pegylated liposomal doxorubicin alone in patients with platinum-resistant/-refractory ovarian cancer.

The investigational AKT inhibitor capivasertib (AZD5363) demonstrated clinical activity in patients with AKT-mutated cancers, suggesting the validity of tailoring treatment to tumor genes.

The FDA has expanded the approval of eltrombopag in combination with standard immunosuppressive therapy to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of nivolumab combined with low-dose ipilimumab as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.

The European Medicine’s Agency Committee for Medicinal Products for Human Use has recommended expanding the approval of ribociclib (Kisqali) in women with HR+/HER2-negative breast cancer to include use in combination with fulvestrant (Faslodex).

The European Commission has approved cabozantinib (Cabometyx) for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar), according to Ipsen, which develops the multikinase inhibitor with Exelixis.

Second-line treatment with pembrolizumab improved overall survival versus chemotherapy in patients with advanced or metastatic esophageal or esophagogastric junction carcinoma whose tumors expressed PD-L1.

The FDA has granted a priority review designation to a supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

The FDA has granted a fast track designation to selinexor for the treatment of patients with previously treated diffuse large B-cell lymphoma who are ineligible to receive high-dose chemotherapy with stem cell rescue or CAR T-cell therapy.

The FDA has granted an approval to pegfilgrastim-cbqv, a pegfilgrastim biosimilar, for patients with cancer receiving myelosuppressive chemotherapy, according to Coherus BioSciences, Inc, the manufacturer of the agent.

The efficacy of combination therapy with a checkpoint inhibitor and chemotherapy has been proved in the triple-negative breast cancer space, and the additive and early toxicity may be worth the survival benefit, according to Lisa A. Carey, MD.

Although the first steps have been taken with immunotherapy in breast cancer, Sherene Loi, MBBS, FRACP, PhD, FAHMS, said development is still lagging in HER2-positive disease because of effective anti-HER2 therapies available.

Hetty Carraway, MD, highlights ongoing genomic research in acute myeloid leukemia, as well as recent therapeutic advances in the field.

The first-line triplet of atezolizumab, carboplatin, and nab-paclitaxel was associated with a statistically significant improvement in both progression-free and overall survival compared with chemotherapy alone in patients with stage IV nonsquamous NSCLC, according to results from the phase III IMpower130 trial.

Frontline pembrolizumab monotherapy showed an improvement in overall survival and duration of response versus standard therapy in patients with PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma; however, there was not a similar improvement in progression-free survival or overall response rate with the PD-1 inhibitor.

The combination of avelumab and axitinib doubled objective response rates and significantly improved progression-free survival compared with sunitinib in patients with treatment-naïve advanced renal cell carcinoma regardless of PD-L1 expression.

The combination of palbociclib plus fulvestrant led to a clinically meaningful benefit in overall survival in patients with hormone receptor–positive, HER2-negative advanced breast cancer who had progressed or relapsed on prior endocrine therapy.

The addition of atezolizumab to nab-paclitaxel reduced the risk of progression or death by 38% compared with nab-paclitaxel alone in patients with PD-L1–positive metastatic triple-negative breast cancer.

MET amplification and EGFR C797S mutations are the most commonly observed alterations associated with resistance to first-line osimertinib in patients with EGFR-mutant non–small cell lung cancer.

The FDA has granted olaparib an orphan drug designation for the treatment of patients with pancreatic cancer.

The FDA has approved talazoparib (Talzenna) for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

Ado-trastuzumab emtansine (T-DM1; Kadcyla) was found to significantly reduce the risk of disease recurrence or death compared with trastuzumab (Herceptin) as an adjuvant treatment in patients with HER2-positive early breast cancer who have residual disease following neoadjuvant therapy.

The FDA has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have progressed on prior treatment, and have no other acceptable alternative treatment options.

Single-agent nivolumab (Opdivo) did not improve overall survival compared with standard topotecan or amrubicin, where approved, in patients with small cell lung cancer who relapsed following platinum-based chemotherapy.

Aaron Gerds, MD, discusses the activity and drawbacks with current systemic agents in myeloproliferative neoplasms.

Hope S. Rugo, MD, discusses the highly anticipated studies of immunotherapy in triple-negative breast cancer and where the class of agents optimally fits in the landscape.

Advances in subtype-specific treatments, immunotherapy, ongoing issues with younger patients, the optimal use of neoadjuvant and adjuvant regimens, and molecular testing will be discussed at the 20th Annual Lynn Sage Breast Cancer Symposium.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended full approval of brigatinib (Alunbrig) as a treatment for patients with advanced ALK-positive non–small cell lung cancer who are previously treated with crizotinib (Xalkori).

Richard Riedel, MD, discussed the presentation and standard management of uterine sarcomas, the potential role of immunotherapy and targeted agents, and the challenges he hopes to overcome in the landscape in the near future.