News

An update to the phase II study of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma showed promising overall response rate, according to a press release from ADC Therapeutics SA.

The phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in patients with advanced T-cell lymphomas, has been placed on a partial clinical hold by the FDA. The decision was made following discussions regarding Good Manufacturing Practice deficiencies at a subcontractor site that manufacturers the agent in December of 2019, according to a press release from Innate Pharma SA.

In an interview with Targeted Oncology, Wasif M. Saif, MD, discussed the current treatment landscape and recent expansions in hepatocellular carcinoma that are providing him with hope for the field.

The combination of pembrolizumab and chemotherapy improved progression-free survival in patients with small cell lung cancer compared with chemotherapy alone, meeting 1 of the primary end points of the phase III KEYNOTE-604 study, according to a press release from pembrolizumab developer, Merck. Compared with a chemotherapy regimen of either etoposide plus cisplatin or cisplatin alone, the progression-free survival mprovement with pembrolizumab was significant.

Pembrolizumab is now FDA approved for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

The overall response rate was improved with itacitinib plus corticosteroids compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease in the phase III GRAVITAS-301 trial. However, the difference in ORR for the treatment arm compared with the placebo arm was not statistically significant, missing the trial’s primary end point.

In an interview with&nbsp;<em>Targeted Oncology</em>, Constantine S. Tam, MD, discussed the findings of&nbsp;the phase III CAPTIVATE study.&nbsp;

The Ion Torrent Oncomine Myeloid Research Assay, the first fully-integrated next-generation sequencing platform, will be available in 2020 on the new Ion Torrent Genexus System for research use, according to a press release from Thermo Fisher Scientific. The platform features automated workflow to allow for result delivery within a single day, requiring minimal user intervention and tissue sample input.

In an interview with&nbsp;Targeted Oncology, Courtney D. DiNardo, MD, discussed the interim analysis results from the ongoing phase II trial evaluating the combination of enasidenib plus azacitidine in newly diagnosed patients with acute myeloid leukemia.

A phase Ib/2 clinical trial has been initiated to assess the anti-tumor activity of FGFR4 targeted therapy fisogatinib plus the anti&ndash;PD-L1 monoclonal antibody CS1001 for the treatment of patients with locally advanced or metastatic hepatocellular carcinoma.

In an interview with Targeted Oncology at the 2019 San Antonio Breast Cancer Conference, Antionette Tan, MD, shared the results of the FeDEriCa study and explained how the results can impact the treatment of patients with HER2-positive breast cancer in the clinical setting.

Overall survival was significantly improved in patients with locally advanced or metastatic urothelial cancer who received first-line maintenance treatment with avelumab versus standard of care, meeting the primary end point of the phase III JAVELIN Bladder 100 study, Pfizer announced in a press release.

Infigratinib has been granted Fast Track Designation by the FDA for the treatment of cholangiocarcinoma in adult patients with first-line advanced or metastatic disease, according to a press release from QED Therapeutics, a subsidiary of BridgeBio Pharma, Inc, and developer of infigratinib.

In an interview with&nbsp;Targeted Oncology&nbsp;at the 2019 Ruesch Symposium, Fearon, professor, Weil Cornell Medicine, discussed his presentation on the CXCL-12 pathway, which can exclude T cells from pancreatic ductal adenocarcinoma. He also shared his opinion on how to advance the treatment landscape in the future.

CLR 131, a small-molecule, targeted Phospholipid Drug Conjugate, has been granted Orphan Drug Designation by the FDA for the treatment of patients with lymphoplasmacytic lymphoma, according to a press release from Cellectar BioSciences, Inc, developer of the drug.<br /> &nbsp;

The FDA granted approval to countless treatments across cancer types throughout 2019 until the end of the year, with a final approval on December 31^st&nbsp;for the first BRCA targeted therapy in pancreatic cancer. Following the excitement for a new year of further advances,&nbsp;Targeted Oncology&nbsp;followers on Twitter shared their thoughts on some of the most impactful FDA approvals in 2019.

The FDA released a draft guidance document entitled &ldquo;Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry&rdquo; to clarify the evidence required to prove the effectiveness of drugs and biologics. The statement is a supplement for the 1998 guidance entitled &ldquo;Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.&rdquo; The draft guidance is designed to aid the submission of&nbsp; new drug applications, biologics license applications, or applications for supplemental indications.

In an interview with&nbsp;Targeted Oncology, Nizar Bahlis, MD, discussed the updated findings from the MAIA trial, which he presented at the 2019 ASH Annual Meeting. He highlighted the updates to the PFS, OS, and overall response rate data, as well as some other areas daratumumab is under investigation now following the positive data from this trial.&nbsp;

Individuals with obesity who were diagnosed with locally advanced or metastatic clear cell renal cell carcinoma achieved longer overall survival than patients of normal weight in select groups of an independent cohort study, which evaluated overall survival and the transcriptomic differences in the primary tumor and peritumoral adipose tissue in adult patients with metastatic clear cell renal cell carcinoma.

In a preliminary clinical trial, ARQ 531, an&nbsp;investigational Bruton tyrosine kinase inhibitor, showed safety and clinical activity across a variety of B-cell malignancies.

With the absence of a standard of care for chronic neutrophilic leukemia and atypical chronic myeloid leukemia, 2 rare&nbsp;BCR-ABL1-negative myeloid neoplasms, ruxolitinib may be a viable treatment option after a phase II study showed potential for response in this patient population.

In December 2019, the FDA approved a number of new treatments in lung cancer, pancreatic cancer, urothelial carcinoma, breast cancer, and prostate cancer. A&nbsp;tissue complete assay was also approved by the FDA for use in a clinical trial evaluating pembrolizumab.

During a&nbsp;Targeted Oncology&nbsp;tweet chat, Erika P. Hamilton, MD, and Stephanie Graff, MD, discussed treatment options and considerations for the case of a patient with ER-positive, HER2-negative breast cancer who relapsed on letrozole, an aromatase inhibitor.

Ado-trastuzumab emtansine has been approved by the European Commission for the treatment of adult patients with HER2-positive early breast cancer, in the adjuvant setting who have residual invasive disease after taxane-based chemotherapy &nbsp;and HER2-targeted therapy, in the neoadjuvant setting.¹

Adult patients&nbsp;with&nbsp;deleterious or suspected deleterious&nbsp;germline&nbsp;<em>BRCA</em>-mutated metastatic pancreatic adenocarcinoma who have not had disease progression on at least 16 weeks of first-line platinum-based chemotherapy may now receive maintenance therapy with the&nbsp;PARP inhibitor olaparib, according to an approval from the FDA.

Osimertinib demonstrated a manageable toxicity profile and encouraging activity in patients with non&ndash;small cell lung cancer who harbor an uncommon EGFR mutation, according to results from a phase II clinical trial conducted in Korea.

In an interview with&nbsp;Targeted Oncology&nbsp;at the 2019 Ruesch Center Symposium, Benjamin Weingberg, MD, shared key points from his discussion on mining the microbiome in patients with colorectal cancer and summarized the treatment landscape for patients with metastatic disease. He also discussed an upcoming basket trial that uses liquid biopsies to place patients on treatment plans that will be most effective for their individual needs.

The combination of off-the-shelf, antibody-targeted natural killer cells and IL-15 superagonist N-083 with low-dose metronomic chemoradiation, adenoviral and year tumor-associated antigen vaccines, and a PD-L1 checkpoint inhibitor had ongoing durable complete responses in patients with triple-negative breast cancer who failed standard-of-care treatment, according to a press release from NantKwest Inc., manufacturer of the NK cell-based therapy.

Results from a phase II prospective trial indicate that fluorouracil-, leucovorin-, irinotecan-, and oxaliplatin-based treatment and imaging-based biomarkers for borderline resectable pancreatic ductal adenocarcinoma achieved a resection rate of 45% and a median overall survival of 2 years.<br /> &nbsp;

The Cchek Prostate Cancer Confirmation test&mdash;which utilizes artificial intelligence, flow cytometry, and liquid-biopsy technology to detect prostate cancer&mdash;has been commercially launched, according to Anixa Biosciences, Inc., developer of the test. Once it becomes available, this test will reduce the need for expensive and invasive biopsy procedures to diagnose patients with prostate cancer in certain patients.<br /> &nbsp;