Breakthrough Lymphoma Drug Highlights Week in Cancer News

Top news of the week in oncology and cancer drug development.

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Abemaciclib Improves PFS in Phase III MONARCH 3 Breast Cancer Trial

Adding abemaciclib to letrozole or anastrozole improved progression-free survival (PFS) compared with either aromatase inhibitor alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 3 study, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor. MONARCH 3 (NCT02246621) is the second phase III trial of abemaciclib to demonstrate improved PFS in patients with HR+/HER2-negative breast cancer.

In March, Lilly announced that in the MONARCH 2 study, combining abemaciclib with fulvestrant extended PFS compared with fulvestrant alone in patients who had progressed during or within 1 year of receiving endocrine therapy in the neoadjuvant or adjuvant setting, or during frontline endocrine treatment for metastatic disease. The detailed findings from the MONARCH 3 trial will be presented at a medical conference later this year, Lilly reported in a press release. The company plans to submit results to the FDA this year from both the MONARCH 2 and 3 trials, as well as from the phase II MONARCH 1 trial.

See more: http://www.onclive.com/web-exclusives/abemaciclib-improves-pfs-in-phase-iii-monarch-3-breast-cancer-trial

Nivolumab Provides Durable Responses in Sorafenib-Experienced HCC Patients

Sorafenib-experienced patients with advanced hepatocellular carcinoma (HCC) had long-term responses to nivolumab (Opdivo) of more than 1 year, according to findings from the CheckMate-040 trial presented at the 2017 International Liver Congress. At a median follow-up of 12.9 months, the objective response rate (ORR) by blinded independent central review was 14.5%, and the ORR was 19.3% by investigator assessment.

At present, response is ongoing in 71.4% of patients, and the median duration of response was not reached. The 12-month overall survival (OS) rate was 59.9% and median OS was 16.7 months. “HCC is the second most common cause of cancer-related deaths worldwide. There are no standard treatment options for patients with advanced HCC who progress on sorafenib, and the prognosis is poor for these patients,” said researcher Jörg Trojan MD, Goethe University Hospital and Cancer Center in Frankfurt, Germany. “The durable responses and survival rates that were achieved with nivolumab are very encouraging, particularly as the side effects were manageable.”

See more: http://www.onclive.com/conference-coverage/liver-2017/nivolumab-provides-durable-responses-in-sorafenibexperienced-hcc-patients

Veliparib Falls Short in Phase III NSCLC, TNBC Trials

Veliparib failed to meet the primary endpoint in phase III non—small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC) trials, according to AbbVie, the company developing the PARP inhibitor. Both trials examined the use of veliparib in combination with carboplatin and paclitaxel. AbbVie noted in a statement that the complete data from the studies will be presented at an upcoming medical meeting or published in a peer-reviewed journal.

"Research shows there is a role for PARP inhibitors in cancers associated with DNA repair deficits, such as those with BRCA mutations. In these clinical trials, we wanted to explore whether a PARP inhibitor could augment chemotherapy in patients with squamous non—small cell lung cancer and triple-negative breast cancer by disrupting the repair of cancer cells," Gary Gordon, MD, PhD, vice president, oncology clinical development, AbbVie, said in a statement. "Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients."

Veliparib continues to be explored in ongoing phase III trials in ovarian cancer, BRCA1/2-positive breast cancer, and nonsquamous NSCLC.

See more: http://www.onclive.com/web-exclusives/veliparib-falls-short-in-phase-iii-nsclc-tnbc-trials

FDA Grants CTL019 Breakthrough Designation for DLBCL

The FDA has granted a breakthrough therapy designation to tisagenlecleucel-T (CTL019) for use as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma after the failure of at least 2 prior therapies, according to Novartis, the developer of the CAR T-cell therapy. The designation is based on results from the multicenter phase II JULIET study (NCT02445248). Novartis intends to present the trial findings at an upcoming medical meeting.

Breakthrough therapy designation is meant to expedite the development of promising medications that have shown preliminary signs of clinical efficacy. Under the program, the FDA will be more accessible, in order to provide advice on the design and conduct of the clinical development program. Tisagenlecleucel-T previously received a breakthrough therapy designation for the treatment of pediatric and young adult patients with relapsed/refractory B-cell ALL.

Last month, the FDA granted a priority review designation to an application for tisagenlecleucel-T for use in this setting. Under the priority review program, the FDA will decide on the BLA for tisagenlecleucel-T within 6 months compared with the standard 10-month review.

See more: http://www.onclive.com/web-exclusives/fda-grants-ctl019-breakthrough-designation-for-dlbcl

FDA Approves Frontline Atezolizumab for Some Bladder Cancer Patients

The FDA has granted an accelerated approval to atezolizumab (Tecentriq) as a frontline treatment for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (mUC), according to Genentech, the manufacturer of the PD-L1 inhibitor. The approval is based on data from the single-arm phase II IMvigor210 trial. In a study cohort of 119 cisplatin-ineligible, treatment-naive patients, the objective response rate (ORR) with atezolizumab was 23.5% (n = 28; 95% CI, 16.2-32.2), including a complete response (CR) rate of 6.7%.

The median duration of response was not yet reached. Among patients with PD-L1 expression ≥5% (n = 32), the ORR was 28.1% (95% CI, 13.8-46.8), including a CR rate of 6.3%. In patients with PD-L1 expression <5%, the corresponding rates were 21.8% (95% CI, 13.7-32.0) and 6.9%, respectively. Based on a separate cohort from the IMvigor210 trial, atezolizumab previously received an accelerated approval as a treatment for patients with locally advanced or mUC whose disease progressed during or after platinum-based chemotherapy, or <12 months of receiving platinum-containing chemotherapy, either before or after surgery.

See more: http://www.onclive.com/web-exclusives/fda-approves-frontline-atezolizumab-for-some-bladder-cancer-patients

FDA Schedules ODAC Meeting for Neratinib in HER2+ Breast Cancer

The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) hearing for May 24, 2017, to discuss a new drug application (NDA) for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin), according to a statement from the developer of the TKI, Puma Biotechnology. The NDA for neratinib, which the FDA accepted on September 20, 2016, is based on findings from the phase III ExteNET trial and the phase II CONTROL trial.

ODAC will review the efficacy and safety data and make a non-binding recommendation on whether or not the FDA should approve the drug. The NDA was originally anticipated in the first quarter of 2016; however, the submission was delayed following a series of meetings with the FDA in which the agency requested a new statistical analysis of data from the ExteNET trial. For the new analysis, data were censored for patients who missed 2 or more scheduled disease assessments prior to recurrence or death.

In the initial data reported for the phase III ExteNET study, neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. With the new statistical model, the 2-year invasive DFS rates were 94.2% and 91.9% for neratinib and placebo, respectively. This represented a 34% reduction in the risk of disease recurrence or death (HR, 0.66; CI, 0.49-0.90; P = .004), according to data released by Puma.

See more: http://www.onclive.com/web-exclusives/fda-schedules-odac-meeting-for-neratinib-in-her2-breast-cancer