ESMO Annual Congress Updates Highlight Week in Cancer News

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

Niraparib Highly Effective in Ovarian Cancer

Maintenance therapy with the PARP1/2 inhibitor niraparib reduced the risk of progression or death by 73% compared with placebo for patients with germline BRCA-positive platinum-sensitive, recurrent ovarian cancer, according to findings from the phase III NOVA trial.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/niraparib-highly-effective-as-maintenance-therapy-for-recurrent-ovarian-cancer

Pembrolizumab New Standard Frontline Therapy for NSCLC

Single-agent pembrolizumab reduced the risk of death by 40% and improved progression-free survival by 4.3 months compared with doublet chemotherapy for untreated patients with advanced non—small cell lung cancer with PD-L1 expression on ≥50% of cells, according to findings from the phase III KEYNOTE-024 trial.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/frontline-pembrolizumab-practicechanging-for-advanced-nsclc

Frontline Cabozantinib Bests Sunitinib in mRCC

Cabozantinib reduced the risk of progression or death by 31% compared with sunitinib in the frontline setting for patients with metastatic renal cell carcinoma, according to results from the phase II CABOSUN trial. The median progression-free survival was 2.6 months higher with cabozantinib versus sunitinib.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/frontline-cabozantinib-bests-sunitinib-in-mrcc

Adjuvant Sunitinib Extends DFS in RCC

Adjuvant sunitinib prolonged disease-free survival by 1.2 years compared with placebo following nephrectomy for patients with high-risk clear cell renal cell carcinoma, according to findings from the phase III S-TRAC trial.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/adjuvant-sunitinib-extends-dfs-for-highrisk-rcc

Ribociclib Shows Major PFS Increase in Breast Cancer

The ribociclib plus letrozole reduced the risk of progression or death by 44% compared with letrozole and placebo for postmenopausal women with HR-positive metastatic breast cancer, according to phase III findings from the MONALEESA-2 trial.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/ribociclib-leads-to-major-pfs-increase-in-hr-metastatic-breast-cancer

Second-Line Atezolizumab Extends Survival in NSCLC

Atezolizumab reduced the risk of death by 27% compared with docetaxel in patients with advanced non—small cell lung cancer following the failure of platinum-based chemotherapy, according to findings from the phase III OAK trial. The median overall survival was improved by 4.2 months with the PD-L1 inhibitor versus chemotherapy.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/atezolizumab-significantly-extends-survival-in-nsclc

Fulvestrant Bests Anastrozole in Breast cancer

First-line treatment with fulvestrant led to a 2.8 month improvement in progression-free survival compared with anastrozole for patients with HR-positive advanced breast cancer, according to findings from the phase III FALCON trial.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/fulvestrant-bests-anastrozole-in-phase-iii-breast-cancer-study

Ceritinib Established as Second-Line Standard for ALK+ NSCLC

Progression-free survival was more than 3 times longer with ceritinib than with chemotherapy for patients with advanced ALK-positive non—small cell lung cancer who progressed after first-line crizotinib, according to phase III findings from the ASCEND-5 study.

See more http://www.onclive.com/conference-coverage/esmo-2016-congress/ceritinib-establishes-pfs-advantage-in-second-line-alk-nsclc

Nivolumab Misses Mark in CheckMate-026 Trial

Frontline treatment with nivolumab resulted in a median progression-free survival of 4.2 months compared with 5.9 months with doublet chemotherapy for patients with non—small cell lung cancer. Overall survival and response rate also did not differ significantly between treatment groups. Additionally, a benefit was not observed for nivolumab versus chemotherapy in those with PD-L1 expression on ≥50% of cells, with a HR for PFS of 1.07 and an HR of 0.90 for OS.

See more http://www.onclive.com/web-exclusives/nivolumab-misses-pfs-endpoint-in-first-line-advanced-nsclc

Priority Review Granted to Daratumumab Triplets for Myeloma

The FDA granted a priority review designation to daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy. The priority review was based on findings from the phase III POLLUX and CASTOR studies. '

In the phase III POLLUX trial, adding daratumumab to lenalidomide and dexamethasone reduced the risk of progression or death by 63% versus lenalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma. In the phase III CASTOR trial, the addition of daratumumab to bortezomib and dexamethasone reduced the risk of progression or death by 61% compared with the 2 drugs alone for patients with recurrent or refractory multiple myeloma. The FDA is scheduled to make a final decision on the supplemental application for the triplet regimens by February 17, 2017.

See more http://www.onclive.com/web-exclusives/fda-grants-priority-review-to-daratumumab-triplets-for-relapsed-myeloma

FDA Grants Alectinib Breakthrough Designation for Frontline ALK+ NSCLC

The FDA granted a breakthrough therapy designation to alectinib as a frontline treatment for patients with ALK-positive non—small cell lung cancer. The designation, which is meant to expedite the development of promising new therapies, was based on findings from the phase III J-ALEX study, in which alectinib reduced the risk of disease progression or death by 66% compared with the current first-line standard, crizotinib, in patients with advanced or recurrent ALK-positive NSCLC.

The median progression-free survival was not reached (95% CI, 20.3—not estimated) in the alectinib cohort compared with 10.2 months (95% CI, 8.2-12) in the crizotinib arm (HR, 0.34; 99% CI, 0.17-0.70; P <.0001). In the subgroup of patients with brain metastases at baseline, the hazard ratio for PFS with alectinib versus crizotinib was 0.08 (95% CI, 0.01-0.61). The investigator-assessed objective response rates were 85.4% in the alectinib group and 70.2% in the crizotinib arm. By the independent review, the ORR was 91.6% in alectinib cohort.

See more http://www.onclive.com/web-exclusives/fda-grants-alectinib-breakthrough-designation-for-frontline-alk-nsclc