Jason M. Broderick

A pathologic complete response rate of 44% was observed with a neoadjuvant durvalumab (Imfinzi)-based regimen administered to patients with triple-negative breast cancer, according to results of a phase I/II study presented in a poster at the 2019 San Antonio Breast Cancer Symposium.

In patients with triple-negative breast cancer or those with PD-L1–positive breast cancer across several subtypes, durvalumab as maintenance therapy, may improve outcomes compared with chemotherapy, according to an exploratory analyses from the phase II randomized SAFIR02-IMMUNO trial presented at the 2019 San Antonio Breast Cancer Symposium.

Frontline treatment with palbociclib demonstrated positive progression-free survival n real-world patients with HR-positive/HER2-negative metastatic breast cancer and may lead to an overall survival benefit , according to data from the pivotal PALOMA-2 trial.

Patients with HER2-positive metastatic breast cancer who had received prior anti-HER2 therapies continued to experience a progression-free survival benefit with margetuximab and a trend toward overall survival compared with trastuzumab when either agent was combined with chemotherapy, according to updated findings from the phase III SOPHIA trial. 

In the phase II HER2CLIMB trial, a 34% reduction in the risk of death was observed with the addition of tucatinib to the combination of trastuzumab and capecitabine in patients with heavily pretreated unresectable locally advanced or metastatic HER2-positive breast cancer compared to the combination alone, according to results from the phase II HER2CLIMB trial presented at the 2019 San Antonio Breast Cancer Symposium.

In the phase III CANDOR trial, the addition of daratumumab to carfilzomib and dexamethasone reduced the risk of disease progression or death by 37% compared with carfilzomib and dexamethasone alone in patients with relapsed/refractory multiple myeloma, according to findings from the phase III CANDOR trial presented at the 2019<br /> American Society of Hematology Annual Meeting.

Data from the&nbsp;phase Ib/II CARTITUDE-1 trial that were presented at the 2019 ASH Annual Meeting demonstrated the anti-BCMA CAR T-cell therapy JNJ-4528 achieved a 100% overall response rate with responses in 29 patients with heavily pretreated relapsed/refractory multiple myeloma.<br /> &nbsp;

Immunotherapy combination regimens have revolutionized the first-line treatment paradigm for patients with clear cell renal cell carcinoma, explained Robert J. Motzer, MD, at the <em>37th Annual</em> CFS.

There are at least two dozen different B-cell maturation antigen-directed therapies being explored in clinical trials, Sham Mailankody, MBBS, told attendees at the 37 Annual CFS.&nbsp;Mailankody, an assistant attending physician at Memorial Sloan Kettering Cancer Center in New York, New York, highlighted the most promising anti-BCMA agents across several modalities, including CAR T-cell therapy, bispecific antibodies, and antibody-drug conjugates.

Findings from part 1 of the phase II/III RESILIENT trial of irinotecan hydrochloride liposome injection in second-line treatment of small cell lung cancer showed that for close to 50% of patients, disease control was maintained at 12 weeks. These data were presented at the 2019 World Conference on Lung Cancer.

The combination of&nbsp;atezolizumab plus carboplatin and nab-paclitaxel demonstrated a clinical overall survival benefit in a subgroup of patients with&nbsp;advanced squamous non&ndash;small cell lung cancer and a high level of PD-L1 expression in the phase III IMpower131 trial. Final data for this study was presented at the 2019 World Conference on Lung Cancer.

The review period has been extended by the FDA for a&nbsp;supplemental biologics license application for atezolizumab as a frontline treatment for patients with&nbsp;metastatic nonsquamous non&ndash;small cell lung cancer who do not have <em>EGFR</em> or <em>ALK</em> aberrations, in combination with&nbsp;carboplatin and nab-paclitaxel.

The combination of atezolizumab and nab-paclitaxel has been approved by the European Commission as a frontline treatment for adult patients with unresectable, locally advanced, or metastatic PD-L1&ndash;positive triple-negative breast cancer, a result of the positive outcomes in the phase III IMpassion130 trial.

The FDA has drafted new industry recommendations for sponsors to encourage male inclusion in clinical trials for breast cancer.<br /> &nbsp;

The phase III IMvigor130 study showed significant improvement in progression-free survival with the combination of&nbsp;Atezolizumab and chemotherapy in patients with&nbsp;previously untreated locally advanced or metastatic urothelial carcinoma, according to a recent press release from manufacturer, Genentech.

The approval of TAS-102 has been backed by the&nbsp;European Medicines Agency&#39;s Committee for Medicinal Products for Human Use for the treatment of&nbsp;adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction, in those previously treated with at least 2 prior systemic therapy regimens for advanced disease.

Cemiplimab has been approved by the&nbsp;European Commission for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

A complete response letter has been issued to&nbsp;Daiichi Sankyo from the FDA, alerting the company to the reasons why the new drug application for quizartinib as a&nbsp;treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia would not be approved.&nbsp;

Polatuzumab vedotin in combination with&nbsp;bendamustine and rituximab has been granted an accelerated approval from the FDA for the&nbsp;treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.<br /> &nbsp;

Combining neratinib with capecitabine showed a 24% reduction in the risk of disease progression or death compared with lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer who had previously received 2 lines of HER2-targeted therapy,&nbsp;according to the results of the phase III NALA trial presented at the 2019 ASCO Annual Meeting.

Compared to chemotherapy, treatment with the PARP inhibitor olaparib reduced the risk of disease progression or death by 38% in patients with platinum-sensitive, relapsed, germline&nbsp;<em>BRCA1/2</em>-mutated ovarian cancer who had received at least 2 prior chemotherapy regimens, based on topline findings from the confirmatory phase III SOLO3 trial.

Half of patients with&nbsp;<em>KRAS</em> G12C&ndash;positive advanced non&ndash;small cell lung cancer achieved a response from treatment with the&nbsp;investigational KRAS G12C inhibitor, AMG 510, in a phase I study presented at the 2019 ASCO Annual Meeting.

When the targeted agents&nbsp;ramucirumab and erlotinib were combined, progression was delayed by 7 months in patients with newly diagnosed&nbsp;<em>EGFR</em>-positive non&ndash;small cell lung cancer compared to erlotinib alone, according to findings from the phase III RELAY trial.&nbsp;

Progression-free survival was significantly improved with the triplet combination of&nbsp;isatuximab,&nbsp;pomalidomide, and low-dose dexamethasone compared with pomalidomide and dexamethasone alone in patients with&nbsp;relapsed/refractory multiple myeloma, according to findings from the phase III ICARIA-MM trial presented at the 2019 ASCO Annual Meeting.<br /> &nbsp;

Single-agent lurbinectedin induced an overall response rate of 35.2% in the second-line setting for the treatment of patients with small cell lung cancer in a phase II basket trial, presented at the 2019 ASCO Annual Meeting.

Patients with metastatic castration-resistant prostate cancer who received&nbsp;apalutamide plus androgen deprivation therapy had a 33% reduced risk of death compared with patients taking androgen deprivation therapy alone in the phase III TITAN trial. Topline results from the trial were&nbsp;presented at the 2019 ASCO Annual Meeting and simultaneously published in the <em>New England Journal of Medicine.</em>

A new drug application for&nbsp;tazemetostat was submitted to the FDA for the treatment of patients with&nbsp;epithelioid sarcoma who are not eligible for curative surgery, according to Epizyme, the&nbsp;manufacturer of the EZH2 inhibitor.

The R²&nbsp;regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) has been approved by the FDA for the treatment of patients&nbsp;with previously treated follicular lymphoma and marginal zone lymphoma, based on findings from the&nbsp;phase III AUGMENT trial.

One-hundred percent of pediatric patients with CNS and solid tumors harboring&nbsp;<em>NTRK1/2/3</em>, <em>ROS1</em>, or <em>ALK</em> gene fusions or mutations achieved objective responses with entrectinib, according to the phase I/Ib STARTRK-NG trial data presented in a press cast ahead of the 2019 ASCO Annual Meeting.

In an 8-3 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee has recommended against approving a new drug application for quizartinib for adult patients with relapsed/refractory&nbsp;FLT3-ITD&ndash;positive acute myeloid leukemia. The FDA is now scheduled to make a final decision on the application by&nbsp;August 25, 2019.