Phoebe Starr

Late-breaking data from 2 clinical trials presented at ESMO 2019 will likely change the treatment paradigm for pre- or postmenopausal women with hormone receptor (HR)-­positive, HER2-negative breast cancer, regardless of menopausal status. The MONALEESA-3 study and the MONARCH-2 study showed an improved overall survival (OS) with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) or abemaciclib (Verzenio) to endocrine therapy as first- or second-line therapy. The results were presented at the Presidential Session of the meeting. Read Article ›

In a phase 2 “basket” clinical trial, the combination of ipilimumab (Yervoy), a CTLA-4 inhibitor, and nivolumab (Opdivo), a PD-1 inhibitor, led to tumor shrinkage in 44% of patients with rare, aggressive, extrapancreatic high-grade neuroendocrine tumors (NETs), and the responses were durable. No responses were seen in low-grade tumors. These results come from the Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) study, which was presented at the 2019 American Association for Cancer Research annual meeting, by Sandip P. Patel, MD, DART Clinical Study Chair, and Deputy Director, San Diego Center for Precision Immunotherapy, Moores Cancer Center, UC San Diego Health, La Jolla, CA.

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Reduced-dose chemotherapy is as effective as full-dose chemotherapy in frail elderly patients with advanced gastroesophageal cancer, according to results of the phase 3 GO2 clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. Lower doses of oxaliplatin plus capecitabine (OCap) led to similar survival but improved quality of life compared with higher doses of that regimen in this patient population.

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Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

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Gilteritinib (Xospata), a recently approved FLT3 inhibitor, prolonged survival in patients with relapsed or refractory acute myeloid leukemia (AML) and an FLT3 mutation in the phase 3 ADMIRAL clinical trial. A new analysis presented at ASCO 2019 was focused on the impact of baseline co-mutations and FLT3-ITD allelic burden on overall response and on overall survival (OS) in patients with relapsed or refractory AML who received treatment with gilteritinib.

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Results from a new clinical trial suggest that limited access to care is the main contributing factor to the disparities in outcomes that exist between African-American patients and white patients with cancer. Read Article ›

The addition of the cyclin-dependent kinase (CDK)4/CDK6 inhibitor ribociclib to standard endocrine therapy significantly extended overall survival (OS) compared with endocrine therapy alone in premenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, according to results of the phase 3 MONALEESA-7 clinical trial, presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. Read Article ›

In the phase 3 CLL14 clinical trial, fixed-duration venetoclax plus obinutuzumab was superior to chlorambucil plus obinutuzumab as front-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities. The fixed-duration regimen significantly improved progression-free survival (PFS), complete response (CR) rate, and minimal residual disease (MRD) negativity versus chlorambucil plus obinutuzumab, and was superior in patients with poor prognostic factors, such as unmutated IGHV and TP53 alterations. Read Article ›

The FDA has announced the launch of an oncology-specific pilot program for physicians and patients who need access to investigational therapies. The expanded access pilot program is a concierge service, said Richard Pazdur, MD, Director, FDA’s Oncology Center of Excellence, who spoke at a press conference at the 2019 American Society of Clinical Oncology Annual Meeting. Read Article ›

Treatment with gilteritinib (Xospata) significantly improved overall survival (OS) with less toxicity compared with chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) and FLT3 mutation, according to the final results of ADMIRAL, a phase 3 clinical trial presented at the 2019 American Association for Cancer Research meeting. Read Article ›

Immune checkpoint inhibitors represent a tremendous advance in the treatment of several types of cancers. Although approximately 20% to 25% of patients will have durable responses with these agents, it has been challenging to find biomarkers to identify who these patients are. Read Article ›

Preclinical and clinical data support the potential for the investigational novel tyrosine kinase inhibitor (TKI) infigratinib for the treatment of different FGFR-driven tumor types, according to Sameek Roychowdhury, MD, PhD, Associate Professor, Medical Oncology, the Ohio State University, Columbus, who presented a poster with the preclinical results at the 2019 American Association for Cancer Research (AACR) meeting. Read Article ›

The combination of the investigational MET inhibitor savolitinib plus the EGFR inhibitor osimertinib (Tagrisso) achieved encouraging responses in patients with MET-amplified, EGFR-positive non–small-cell lung cancer (NSCLC) and acquired, MET-driven resistance to previous therapies, with an acceptable side-effect profile. These findings represent interim results of 2 expansion cohorts of a phase 1b clinical trial presented at the 2019 American Association for Cancer Research meeting. Read Article ›

Chimeric antigen receptor (CAR) T-cell therapy has had dramatic results in hematologic malignancies, but so far, getting CAR T-cells to work in solid tumors has proved elusive. That may be about to change if promising results from a phase 1 clinical trial are confirmed by further studies. The results of this pivotal study were presented at the 2019 American Association for Cancer Research (AACR) annual meeting. Read Article ›

The investigational PI3K inhibitor umbralisib had encouraging activity as monotherapy in patients with relapsed or refractory marginal-zone lymphoma in an analysis of the phase 2 UNITY-NHL trial. Interim results were presented at the 2019 American Association for Cancer Research (AACR) meeting. Read Article ›

Results with chimeric antigen receptor (CAR) T-cell therapy have been less robust in chronic lymphocytic leukemia (CLL) compared with B-cell acute lymphocytic leukemia and diffuse large B-cell lymphoma. Preliminary studies presented at ASH 2018 ­suggested that a strategy of using CAR T-cell therapy to augment the response to ibrutinib (Imbruvica) holds promise in patients with CLL. Read Article ›

First-line therapy with pembrolizumab (Keytruda) plus ­axitinib (Inlyta) significantly improved overall survival (OS), progression-free survival (PFS), and objective response rates compared with standard-of-care sunitinib (Sutent) in patients with clear-cell metastatic renal-cell carcinoma (RCC) in KEYNOTE-426. The combination of pembrolizumab plus axitinib achieved a significant 47% reduction in mortality risk versus sunitinib (P <.0001). Read Article ›

Darolutamide, an investigational androgen receptor ­inhibitor, significantly improved metastasis-free survival in men with high-risk nonmetastatic castration-resistant prostate cancer (CRPC) compared with placebo in a large phase 3 clinical trial. Read Article ›

A2-year duration of combination immunotherapy with ven­etoclax (Venclexta) and rituximab (Ri­tuxan) improved survival compared with standard-of-care chemoimmunotherapy combination with bendamustine (Ben­deka) plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to follow-up data from the MURANO clinical trial presented at ASH 2018. Early results were first presented at ASH 2017. Read Article ›

The adjuvant use of the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1; Kadcyla) led to a clinically meaningful and statistically significant improvement in invasive disease-free survival (ie, survival free of invasive disease or death) compared with trastuzumab (Herceptin) in patients with HER2-­positive early-stage breast cancer and residual invasive disease, despite the use of neoadjuvant chemotherapy plus HER2-­targeted therapy, according to the preliminary results of the phase 3 KATHERINE trial. These findings were reported at the 2018 San Antonio Breast Cancer Symposium. Read Article ›

On January 14, 2019, the FDA approved cabozantinib (Cabometyx; Exelixis) an oral multitargeted tyrosine kinase inhibitor, for the treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib (Nexavar). Read Article ›

On January 14, 2019, the FDA approved cabozantinib (Cabometyx; Exelixis) an oral multitargeted tyrosine kinase inhibitor, for the treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib (Nexavar). Read Article ›

Triple-negative breast cancer (TNBC) is considered one of the most difficult breast cancers to treat, with few therapeutic options. In an overall analysis of the phase 3 IMpassion130 trial, investigators showed that using the checkpoint inhibitor atezolizumab (Tecentriq), a PD-L1 inhibitor, with nab-paclitaxel (Abraxane) chemotherapy improved disease-free survival (DFS) and overall survival (OS) in patients with advanced or metastatic TNBC compared with placebo plus nab-paclitaxel. Read Article ›

Longer-term follow-up of 2 large pivotal clinical trials in B-cell malignancies has demonstrated continuing remissions after chimeric antigen ­receptor (CAR) T-cell therapy: the ELIANA study in pediatric patients and young adults with relapsed or refractory B-acute lymphoblastic leukemia (B-ALL) and the JULIET study in adult patients with diffuse large B-cell lymphoma (DLBCL). Both updates were presented at a press conference at ASH 2018. Read Article ›

San Antonio, TX—An interim analysis of a randomized clinical trial showed that a lifestyle intervention aimed at weight loss achieved approximately a 1-kg weight loss in patients with early breast cancer who received chemotherapy, whereas patients in the control group gained approximately 1 kg over the course of the study. Read Article ›

A 12-month supervised exercise program improved cardiovascular function in women receiving adjuvant chemotherapy for breast cancer, including anthracyclines and taxanes. These results of a randomized clinical trial were presented at the 2018 San Antonio Breast Cancer Symposium. Read Article ›

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The BCL2 Gly101Val mutation is the first genomic alteration to be identified as responsible for resistance to venetoclax (Venclexta), a potent and effective medication indicated for the treatment of chronic lymphocytic leukemia. Read Article ›

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Although many new treatments, including targeted therapies and immunotherapies, have recently become available for patients with non–small-cell lung cancer, those with small-cell lung cancer have not seen new treatment options in the past 2 decades. Read Article ›

The PD-L1 inhibitor durvalu­mab (Imfinzi) showed an overall survival benefit in patients with unresectable stage III non–small-cell lung cancer (NSCLC) in the phase 3 PACIFIC trial Read Article ›

Immunotherapy combinations are being studied intensively to determine which combinations hold the most promise in specific cancer types. At ASCO 2018, the session “Compelling Combinations: Raising the Bar with Immunotherapy,” which featured 3 new studies that explore chemotherapy plus immunotherapy, got high marks from lead investigator Sibylle Loibl, MD, PhD, Co-chair of the German Breast Group, Neu-Isenburg, Germany, who discussed the results. Read Article ›

Triple-negative breast cancer is considered one of the most difficult to treat breast cancers, with few treatment options, but finally a breakthrough study shows progress by extending patient survival. Read Article ›

A novel oral agent (BLU-667) that targets RET genetic alterations, achieved durable disease control and was safe in patients with lung or thyroid cancers and RET mutations, as demonstrated by the first-in-human phase 1 clinical trial ARROW. Read Article ›

A novel approach using the investigational toll-like receptor 9 (TLR9) agonist CMP-001 in combination with pembrolizumab (Keytruda) may have the potential to reverse resistance to anti–PD-1 therapy, according to data from a preliminary phase 1b clinical trial. Read Article ›

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Genomic testing is now the standard of care for patients with non–small-cell lung cancer (NSCLC). The 4 identified genomic mutations that are targetable with FDA-approved therapies include EGFR, ALK, ROS1, and BRAF, and other NSCLC-associated genetic mutations are targetable with therapies currently being investigated in clinical trials. More genetic mutations are linked to NSCLC, but there is currently no accepted standard for genomic testing in NSCLC, or the optimal timing of such tests. Read Article ›

A burning question is whether immunotherapy combinations will further improve outcomes compared with checkpoint inhibitor therapy alone—and if so, which combinations will rise to the top. Read Article ›

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Chimeric antigen receptor (CAR) T-cell therapy has had excellent results in late-stage leukemia and varying degrees of success in some other hematologic cancers, but thus far, solid tumors have not responded to this therapy. Read Article ›

Metastatic estrogen receptor (ER)-positive breast cancer responds well to anti-ER therapies, but eventually resistance occurs and the drugs fail to work. A new study presented at the 2018 AACR meeting suggests that HER2 mutations can be acquired during metastatic cancer and their development represents a previously unreported mechanism of resistance to treatment. Read Article ›

The combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) extended progression-free survival (PFS) versus standard chemotherapy as first-line treatment for patients with advanced non–small-cell lung cancer (NSCLC) and a high tumor mutational burden (TMB). This finding was unrelated to levels of PD-L1 expression, said Matthew D. Hellmann, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, New York City. Read Article ›

In 2 separate studies, apalutamide (Erleada) and enzalutamide (Xtandi) reduced the risk for metastasis and prolonged metastasis-­free survival in patients with nonmetastatic castrate-resistant prostate cancer (CRPC), according to the results of 2 clinical trials presented at the 2018 Genitourinary Cancers Symposium. Read Article ›

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Adjuvant chemotherapy had impressive gains in disease-free survival (DFS) and metastasis-free survival versus surveillance in upper-tract urothelial cancer (UTUC), according to the results of the phase 3 POUT clinical trial that were presented at the 2018 Genitourinary Cancers Symposium. Read Article ›

Direct oral anticoagulants (DOACs) may soon replace low-molecular-weight heparin (LMWH) as the standard of care for the management of venous thromboembolism (VTE) in patients with cancer, judging by the results of 2 randomized trials presented at ASH 2017. The caveat is that DOACs are associated with more bleeding events, especially in patients with gastrointestinal (GI) cancer who should continue receiving LMWH. Read Article ›

Adding brentuximab vedotin (Adcetris) to doxorubicin, vinblastine, and dacarbazine (A+AVD) instead of the standard regimen with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as frontline treatment for advanced Hodgkin lymphoma reduced the risk for disease progression, death, or the need for additional therapy by 23%, according to new data presented at ASH 2017. Read Article ›

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For the first time, a randomized clinical trial has shown significant tumor shrinkage with a phosphoinositide-3-kinase (PI3K) inhibitor in patients with estrogen receptor (ER)-positive, HER2-negative early breast cancer. The phase 3 study LORELEI compared neoadjuvant therapy with letrozole plus placebo versus letrozole plus taselisib, a PI3K inhibitor, in this patient population. Read Article ›

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The cost of cancer drugs has increased exponentially over the past decade, straining the healthcare system and patients’ ability to pay for them. Pharmaceutical manufacturers continue to increase drug prices through packaging maneuvers and the use of artificial expiration dates, and as a result, some old drugs “in new clothing” remain expensive. Read Article ›

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Tobacco use among patients with cancer is an important, but often overlooked, issue that requires intervention by oncology practices. In recognition of the problem and the gap between the need for intervention and the services delivered, the American Association for Cancer Research (AACR) issued a policy on tobacco use at its 2013 annual meeting. Read Article ›