Gina Columbus

Treatment with entrectinib led to an overall response rate of 77% and a median duration of response of 24.6 months in patients with ROS1 fusion–positive non–small cell lung cancer, according to updated findings of a pooled analysis published in Lancet Oncology.

The presence of circulating tumor DNA and circulating tumor cells following neoadjuvant chemotherapy can be an independent predictor of disease recurrence in patients with early triple-negative breast cancer.

The triplet regimen of atezolizumab, cobimetinib, and vemurafenib was found to improve progression-free survival compared with cobimetinib/vemurafenib plus placebo in patients with previously untreated BRAF V600 mutation–positive advanced melanoma.

Atezolizumab (Tecentriq) in combination with carboplatin and nab-paclitaxel (Abraxane) did not lead to a statistically significant increase in pathologic complete response (pCR) rate compared with carboplatin/nab-paclitaxel alone in patients with early high-risk and locally advanced triple-negative breast cancer,

A biologics license application has been submitted to the FDA for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

Adjuvant pertuzumab (Perjeta) with trastuzumab (Herceptin) plus chemotherapy showed a 0.9% improvement in overall survival and continued to reduce the risk of disease recurrence in patients with HER2-positive early breast cancer.

The CAR T-cell therapy tisagenlecleucel (Kymriah) showed similar real-world efficacy and safety findings to that of the JULIET trial in the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma.

Blinatumomab (Blincyto) as post-reinduction consolidation therapy before hematopoietic stem cell transplantation improved disease-free survival and overall survival by approximately 20% compared with intensive chemotherapy in pediatric and adolescent and young adult patients with high- or intermediate-risk of first relapse of B-cell acute lymphoblastic leukemia.

The combination of lenalidomide (Revlimid) and obinutuzumab (Gazyva) elicited a 100% overall response rate in patients with relapsed indolent non-Hodgkin lymphoma that was refractory to rituximab (Rituxan).

The combination of lenalidomide (Revlimid) and rituximab showed a 34% reduction in the risk of disease progression or death compared with rituximab plus placebo in patients ≥70 years old with indolent non-Hodgkin lymphoma, although it was not found to be statistically significant.

The first-line combination of ibrutinib (Imbruvica) and venetoclax (Venclexta) led to a 75% undetectable minimal residual disease rate in peripheral blood and 72% in bone marrow in patients with chronic lymphocytic leukemia.

Acalabrutinib (Calquence) as a single agent or in combination with obinutuzumab (Gazyva) significantly improved progression-free survival compared with obinutuzumab plus chlorambucil in treatment-naïve patients with chronic lymphocytic leukemia.

Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel was associated with a 73.4% overall response rate in patients with relapsed/refractory multiple myeloma, meeting the primary endpoint of the pivotal phase II KarMMA trial.

The investigational gene therapy nadofaragene firadenovec demonstrated a 3-month complete response rate of 53% in patients with high-grade, Bacillus Calmette-Guérin–unresponsive, non-muscle invasive bladder cancer with carcinoma in-situ with or without concomitant high-grade Ta or T1 papillary disease, meeting the primary endpoint of a phase III trial.

Ahead of the 2019 ASH Annual Meeting, C. Ola Landgren, MD, PhD, shares insight on the potentially practice-changing data in the multiple myeloma paradigm that will be discussed at the conference.

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for December 17, 2019, to discuss a supplemental new drug application for olaparib tablets as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.

China’s National Medical Products Administration has granted marketing authorization for olaparib as a first-line maintenance treatment for adult patients with newly diagnosed advanced germline or somatic BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy.

The FDA has granted a breakthrough therapy designation for abatacept for the prevention of moderate-to-severe acute graft-versus-host disease in patients who have undergone hematopoietic stem cell transplants from unrelated donors.

The FDA has approved atezolizumab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer who do not harbor EGFR or ALK molecular aberrations.

Immunomedics has resubmitted its biologics license application to the FDA for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease.

The trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) has been launched in the United States for all indications of the reference product, including the treatment of patients with HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

The UK’s National Institute for Health and Care Excellence has approved olaparib for the maintenance treatment of adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease responded to platinum-based chemotherapy and harbor BRCA1/2 mutations.

The FDA has scheduled an Oncology Drugs Advisory Committee hearing for December 18, 2019, to discuss data supporting a new drug application for tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery.

The UK National Institute for Health and Care Excellence has approved palbociclib in combination with fulvestrant for the treatment of female patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.

The FDA has granted a priority review designation to pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.

China’s National Medical Products Administration has granted approval to enzalutamide for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic following progression on androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

The FDA has granted a priority review to a new drug application for pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

China’s National Medical Products Administration has approved the combination of pembrolizumab plus carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non–small cell lung cancer.

Single-agent vorasidenib or ivosidenib led to brain penetrance and 2-hydroxyglutarate suppression in patients with low-grade glioma who harbor IDH1 mutations.

The Chinese-manufactured trastuzumab biosimilar HLX02 demonstrated similar objective response rates to the reference product at 24 weeks in patients with treatment-naïve or recurrent metastatic HER2-positive breast cancer.