ASCO Recap Highlights Week in Cancer News

Recent advances and updates in oncology and cancer drug development.

Melanoma

Pembrolizumab Shows 40% OS Rate at 3 Years

Forty percent of patients with advanced melanoma who started taking pembrolizumab during the clinical trial that led to its initial approval were still alive after 3 years, with many responders in remission even after stopping treatment. The median overall survival was 24.2 months. See more http://www.onclive.com/conference-coverage/asco-2016/pembrolizumab-3year-survival-rate-hits-40-in-melanoma

Binimetinib Improves PFS in Melanoma

The MEK inhibitor binimetinib reduced the risk of progression or death by 38% compared with dacarbazine in patients with NRAS-mutant metastatic melanoma. Data are going to be submitted to the FDA from the study; however, there were some complains that dacarbazine may no longer be a valid comparator. See more http://www.onclive.com/conference-coverage/asco-2016/binimetinib-shows-rare-pfs-benefit-in-nrasmutant-melanoma

Ipi/Nivo Benefit Sustained in Long-Term Melanoma Follow-up

At a minimum follow-up of 18 months, the combination of nivolumab and ipilimumab reduced the risk of disease progression by 58% compared with ipilimumab alone, and single-agent nivolumab lowered the risk of progression by 45% versus ipilimumab monotherapy in patients with advanced melanoma. See more http://www.onclive.com/conference-coverage/asco-2016/longterm-followup-sustains-frontline-nivolumabipilimumab-benefit-in-melanoma

Dabrafenib/Trametinib Benefit Illuminated in 3-Year Melanoma Data

The combination of dabrafenib and trametinib continued to demonstrate impressive overall survival and progression-free survival findings for patients with BRAF-mutant metastatic melanoma in 3-year follow-up data from the phase III COMBI-d study. See more http://www.onclive.com/conference-coverage/asco-2016/longterm-data-deepen-dabrafenibtrametinib-benefit-in-melanoma

Avelumab New Standard for Merkel Cell Carcinoma

The PD-L1 inhibitor avelumab demonstrated durable responses and promising early survival data for patients with pretreated metastatic Merkel cell carcinoma. Data from the study are being submitted to the FDA for approval. See more http://www.onclive.com/conference-coverage/asco-2016/avelumab-highly-effective-in-metastatic-merkel-cell-carcinoma

Breast Cancer

Biosimilar Trastuzumab on Horizon for Breast Cancer

A biosimilar version of trastuzumab demonstrated equivalent efficacy and safety to the FDA-approved branded drug in a randomized phase III study among patients with HER2-positive metastatic breast cancer in findings expected to open the door to a less-expensive version of one of the world’s top-selling oncology drugs. See more http://www.onclive.com/conference-coverage/asco-2016/biosimilar-trastuzumab-matches-herceptin-in-efficacy-and-safety

Single-Agent Abemaciclib Effective in Pretreated Breast Cancer

The CDK4/6 inhibitor abemaciclib induced a response rate of nearly 20% in heavily pretreated patients with refractory, hormone-receptor—positive, HER2-negative advanced breast cancer. See more http://www.onclive.com/conference-coverage/asco-2016/abemaciclib-active-against-hrher2-breast-cancer

Ten-Years of Hormonal Therapy May Add Benefits in Breast Cancer

Women who extended their adjuvant therapy with an aromatase inhibitor to 10 years after treatment for their early-stage HR-positive breast cancer reduced their risk of recurrence by more than a third and experienced no new toxicities or worsening of quality of life. See more http://www.onclive.com/conference-coverage/asco-2016/extending-ai-therapy-beyond-5-years-reduces-recurrence-in-hrpositive-breast-cancer

Phase III Confirms Palbociclib PFS Benefit in Breast Cancer

Adding the CDK 4/6 inhibitor palbociclib to letrozole reduced the risk of disease progression by 42% compared with letrozole alone in patients with ER-positive, HER2-negative advanced or metastatic breast cancer. See more http://www.onclive.com/conference-coverage/asco-2016/impressive-upfront-palbociclib-pfs-benefit-confirmed-in-erher2-breast-cancer

Lung Cancer

Rovalpituzumab Tesirine Effective in Biomarker-Defined SCLC

Treatment with the DLL3-targeted antibody-drug conjugate rovalpituzumab tesirine demonstrated single-agent activity and a manageable safety profile for patients with recurrent/refractory small cell lung cancer. In the biomarker group, the response rate was 39%. See more http://www.onclive.com/conference-coverage/asco-2016/rovalpituzumab-tesirine-shows-promising-efficacy-for-sclc

Immunotherapy Combo Effective for SCLC

Treatment with the combination of nivolumab and ipilimumab demonstrated a median overall survival of 7.7 months and a 1-year OS rate of 43% for patients with recurrent small cell lung cancer. See more http://www.onclive.com/conference-coverage/asco-2016/nivolumabipilimumab-combination-active-in-recurrent-sclc

Nivolumab Data Sustained in Long-Term Results for NSCLC

Two-year follow-up data showed sustained improvements in overall survival with nivolumab in pretreated patients with either nonsquamous or squamous non—small cell lung cancer in updated findings from the phase III CheckMate-057 and -017 trials. See more http://www.onclive.com/conference-coverage/asco-2016/nivolumab-survival-benefit-sustained-in-longterm-nsclc-outcomes

Frontline Nivo/Ipi Shows Promising Early Findings for NSCLC

Upfront treatment with the combination of nivolumab and ipilimumab demonstrated an objective response rate of 57% in patients with PD-L1-positive advanced non—small cell lung cancer. See more http://www.onclive.com/conference-coverage/asco-2016/nivolumabipilimumab-frontline-response-nears-60-in-pdl1-nsclc

Dabrafenib/Trametinib Combo Effective in BRAF-Mutant NSCLC

The combination of dabrafenib and trametinib was highly effective as a treatment for patients with BRAF V600E-mutant non—small cell lung cancer. The ORR with the combination was 63%. FDA submission of this data is expected soon. See more http://www.onclive.com/conference-coverage/asco-2016/dabrafenibtrametinib-combo-highly-effective-in-brafmutant-nsclc

Avelumab Effective for Mesothelioma

The immune checkpoint inhibitor avelumab demonstrated clinical activity in patients with advanced or unresectable mesothelioma. The disease control rate was 56.6% and the response rate was 14.3%.See more http://www.onclive.com/conference-coverage/asco-2016/pdl1-inhibitor-avelumab-active-in-advanced-mesothelioma

Alectinib Bests Crizotinib in NSCLC

Alectinib, a second-generation oral ALK-targeting agent, improved progression-free survival by 66% compared with the current standard crizotinib as initial inhibitor therapy in patients with advanced or recurrent ALK-positive non—small cell lung cancer. See more http://www.onclive.com/conference-coverage/asco-2016/alectinib-could-represent-firstline-standard-in-alkpositive-nsclc

Head and Neck Cancer

Nivolumab Improves OS, ORR in Head and Neck Cancer

Treatment with single-agent nivolumab improved overall survival and objective response rates compared with investigator's choice of therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma. Benefits were more pronounced in those with PD-L1 expression on ≥1% of cells. See more http://www.onclive.com/conference-coverage/asco-2016/nivolumab-improves-os-orr-in-phase-iii-head-and-neck-cancer-study

Pembrolizumab Efficacy Displayed in Head and Neck Cancer

Treatment with pembrolizumab elicited an overall response rate of 18% in patients with metastatic or reucrrent head and neck cancer, according to the KEYNOTE-055 study. Pembrolizumab is currently under review by the FDA as a treatment for head and neck cancer, with a decision expected in August. See more http://www.mercknewsroom.com/news-release/oncology-newsroom/updated-findings-keynote-012-keytruda-pembrolizumab-show-continued-be

GU Cancers

Frontline Atezolizumab Effective for Bladder Cancer

Patients with metastatic urothelial carcinoma who were ineligible for standard cisplatin-based chemotherapy achieved a 24% reduction in tumor size and had a median survival of 14.8 months after taking the immunotherapy agent atezolizumab. See more

http://www.onclive.com/conference-coverage/asco-2016/atezolizumab-effective-in-firstline-setting-in-bladder-cancer

Nivolumab 5-Year OS Rate Passes 30% in Advanced RCC

About one third of patients with advanced renal cell carcinoma who were treated with single-agent nivolumab in the second-line setting or later were still alive at 4 and 5 years in long-term follow-up data from phase I and phase II clinical trials. See more

http://www.onclive.com/conference-coverage/asco-2016/nivolumab-5year-os-rate-passes-30-in-advanced-rcc

GI Cancers

IMAB362 Promising for Gastric Cancer

The novel immunotherapy agent IMAB362 that targets CLDN18.2 reduced the risk of death or progression by approximately 50% when added to standard chemotherapy for patients with CLDN18.2-positive advanced gastric cancers during a phase II trial. See more http://www.onclive.com/conference-coverage/asco-2016/novel-gastric-cancer-immunotherapy-scores-robust-phase-ii-results

Tumor Location Impacts Outcomes in CRC

Survival outcomes in patients with KRAS wild-type metastatic colorectal cancer were significantly longer among those with tumors originating on the left versus the right side of the colon, according to a retrospective analysis of the phase III 80405 trial. See more http://www.onclive.com/conference-coverage/asco-2016/tumor-location-linked-to-survival-outcomes-in-metastatic-colorectal-cancer

Adjuvant Capecitabine/Gemcitabine Improves 5-Year OS in Pancreatic Cancer

The addition of capecitabine to standard adjuvant gemcitabine nearly doubled 5-year overall survival rates compared with gemcitabine alone for patients with pancreatic cancer whose tumors were surgically removed. See more http://www.onclive.com/conference-coverage/asco-2016/capecitabine-combo-improves-survival-in-resected-pancreatic-cancer

Myeloma

Stem Cell Transplant Still Vital in Myeloma

Early findings from a phase III clinical trial suggest that patients with multiple myeloma who receive upfront autologous stem cell transplant survive longer without disease progression than those who receive chemotherapy alone. See more http://www.onclive.com/conference-coverage/asco-2016/stem-cell-transplant-continues-to-show-benefit-in-novelagent-era-of-multiple-myeloma

Daratumumab Effective in Phase III CASTOR Study

Daratumumab, when added to the standard two-drug regimen of bortezomib and dexamethasone, reduced the risk of progression or death by 61% compared with the standard regimen alone for patients with recurrent or refractory multiple myeloma. However, there were complaints about the design of the study, as treatment with bortezomib was stopped after just 8 cycles in each arm and patients had received prior bortezomib. See more http://www.onclive.com/conference-coverage/asco-2016/daratumumab-combo-shows-unprecedented-pfs-benefit-in-multiple-myeloma

Hematologic Maligancies

CPX-351 Improves OS in AML

CPX-351 reduced the risk of death by 31% compared with cytarabine and daunorubicin (7+3) for older patients with high-risk, secondary AML. The study showed a median overall survival of 9.56 months with CPX-351 versus 5.95 months with 7+3 (HR, 0.69). See more http://www.onclive.com/conference-coverage/asco-2016/final-phase-iii-data-uphold-cpx351-survival-benefit-in-aml

Nivolumab Delivers Durable Reponses in Hodgkin Lymphoma

Single-agent nivolumab induced responses in 66% of patients with classical Hodgkin lymphoma who had progressed following autologous stem cell transplant and brentuximab vedotin. See more

http://www.onclive.com/conference-coverage/asco-2016/nivolumab-delivers-durable-reponses-in-hodgkin-lymphoma

Pembrolizumab Effective in Hodgkin Lymphoma

About 70% to 80% of patients in 3 separate cohorts of relapsed/refractory Hodgkin lymphoma responded to pembrolizumab, including patients who relapsed after treatment with brentuximab vedotin, patients who failed to respond to brentuximab, patients who relapsed or progressed after autologous stem cell transplant, and those ineligble for ASCT. See more http://www.onclive.com/conference-coverage/asco-2016/high-response-rates-achieved-with-pembrolizumab-in-refractory-hodgkin-lymphoma

CAR Therapies Continue to Show Durable Responses

Three-fourths of patients with advanced lymphoma achieved durable objective responses to treatment with chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19 even after a low-dose chemotherapy conditioning regimen. See more http://www.onclive.com/conference-coverage/asco-2016/car-therapy-achieves-durable-responses-in-refractory-lymphoma

Brain Cancer

Adjuvant Temozolomide Improves 5-Year OS in GBM

Patients with anaplastic glioma who did not have the codeletion of chromosome arms 1p and 19q demonstrated 5-year survival rates of 56% when adjuvant temozolomide was added to radiation therapy compared with survival rates of 44% in patients who did not receive the adjuvant chemotherapeutic agent. See more http://www.onclive.com/conference-coverage/asco-2016/temozolomide-trial-shows-improved-5year-survival-rates-in-anaplastic-glioma

Nivolumab/Ipilimumab Effective for GBM

Single-agent nivolumab demonstrated encouraging signs of activity with a mild adverse event profile for patients with recurrent glioblastoma multiforme. The 12-month overall survival rate was 40% with nivolumab monotherapy. See more http://www.onclive.com/conference-coverage/asco-2016/nivolumab-effective-in-early-stage-study-for-glioblastoma

Older Patients With GBM Tolerate, Benefit From Adjuvant Temozolomide

Adding temozolomide to short-course radiotherapy after surgery in elderly patients with glioblastoma boosted overall survival by nearly 2 months, bringing 1-year survival rates up from 22.2% to 37.8%. See more http://www.onclive.com/conference-coverage/asco-2016/temozolomide-plus-radiotherapy-effective-tolerable-in-older-adults-with-glioblastoma

New Immunotherapy Combos

PD-L1/OX40 Combo Effective Across Solid Tumors

A combination regimen of the PD-L1 inhibitor atezolizumab and the investigational OX40 agonist MOXR0916 was well tolerated and showed early signs of of antitumor activity in solid tumors. See more http://www.onclive.com/conference-coverage/asco-2016/combining-atezolizumab-with-ox40-agonist-shows-promise-in-solid-tumors

PD-1/4-1BB Effective for Solid Tumors

The combination of the 4-1BB agonist utomilumab and the PD-1 inhibitor pembrolizumab was safe and effective as a treatment for patients with advanced solid tumors. See more http://www.onclive.com/conference-coverage/asco-2016/adding-41bb-agonist-to-pembrolizumab-safe-effective-across-solid-tumors

General News

Large Study Provides Credence to Liquid Biopsy Claims

A genomic analysis of circulating tumor DNA in blood samples from more than 15,000 patients representing multiple cancer types demonstrated that the liquid biopsy testing method correlated closely with mutations described in databases and in some cases from tumor biopsies. See more http://www.onclive.com/conference-coverage/asco-2016/large-study-gives-boost-to-liquid-biopsy-testing-for-mutations

Targeted Therapies Effective in Off-Label Indications

Preliminary results of the MyPathway study showed that 23% of patients with 12 different types of advanced cancers responded to molecularly targeted drugs outside of FDA-approved indications. See more http://www.onclive.com/conference-coverage/asco-2016/molecular-targeting-yields-responses-in-12-cancers-in-offlabel-indications