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FDA Fast Track Designation Granted to Navicixizumab for Heavily Pretreated Ovarian Cancer
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The addition of direct oral oral anticoagulants for the management of venous thromboembolism in patients with cancer is the latest change to previous guidelines issued by the American Society of Clinical Oncology.

Patients with high-grade serous ovarian cancer experienced a 32% reduction in the risk of progression or death with frontline combination veliparib plus carboplatin and paclitaxel followed by veliparib maintenance, according to the data from the phase III VELIA trial presented at the 2019 ESMO Congress, and simultaneously published in the New England Journal of Medicine.

Using a measure known as the growth modulation index, patients with TRK fusion–positive cancers who were treated with larotrectinib had a clinically meaningful improvement in progression-free survival compared with the time to progression on their prior treatment, an analysis of patients enrolled in 1 of 3 clinical trials has found.

Due to treatment benefit observed in pediatric patients with acute lymphoblastic leukemia, 2 clinical trials investigating blinatumomab (Blincyto) versus chemotherapy were stopped early, according to the drug developer Amgen.

In the CheckMate-358 study, the combination of nivolumab and ipilimumab showed durable clinical activity in patients with recurrent or metastatic cervical cancer, regardless of tumor PD-L1 expression.

The risk of progression or death was reduced by 63% with ivosidenib as treatment of pretreated patients with IDH1-mutant advanced cholangiocarcinoma compared with placebo, according to data from the phase III ClarIDHy study that was presented at the 2019 ESMO Congress.

Three clinical trials presented at the 2019 ESMO Congress show that the tropomyosin receptor kinase inhibitor larotrectinib continues to show anti-tumor activity, including long-lasting objective responses and low toxicity, according to results from an integrated analysis.

Robert L. Coleman, MD, FACOG, FACS, discusses the results of the phase III VELIA trial in patients with advanced ovarian cancer.

The combination of olaparib and bevacizumab as frontline maintenance improved the median progression-free survival by 5.5 months over bevacizumab and placebo in patients with newly diagnosed, advanced ovarian cancer following prior treatment with a platinum-based chemotherapy plus bevacizumab, according to the phase III PAOLA-1 findings presented at the 2019 ESMO Congress.

Median progression-free survival was improved by 5.6 months with PARP inhibitor niraparib as first-line treatment for patients with newly diagnosed, advanced ovarian cancer who responded to platinum-based chemotherapy compared with placebo, according to data from the phase III PRIMA study presented at the ESMO Congress 2019 and simultaneously published in the <em>New England Journal of Medicine</em>.

Cediranib in combination with olaparib demonstrated an improvement in progression-free survival when used as treatment for patients with platinum-resistant ovarian cancer (PROC). However, the difference in PFS compared with chemotherapy did not achieve statistical significance, according to a randomized trial presented at the 2019 ESMO Congress.

An objective response rate of 35.5% was seen with treatment with pemigatinib, a selective oral inhibitor of FGFR1, 2, and 3, in patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an <em>FGFR2 </em>rearrangement or fusion, according to findings from the phase II FIGHT-202 clinical trial presented at ESMO 2019.

Gulam A. Manji, MD, PhD, discusses the need to identify mutations that may be actionable in patients with colorectal cancer. The identification of such mutations can further impact patient survival and improve efficacy, says Manji, in both CRC and other gastrointestinal cancers.

In an interview with <em>Targeted Oncology</em>, Marcelo C. Pasquini, MD, discussed the importance of obtaining real-world data and establishing registries for collecting patient outcomes, and how real-world data compare with data from pivotal trials. He also explained the challenges with accessibility to CAR T-cell therapies.

Amol K. Narang, MD, discusses the unanswered questions that still need to be addressed to further expand the role of stereotactic body radiation therapy in gastrointestinal cancers.

Thomas J. Herzog, MD, provided an overview of clinical research in cervical, endometrial, and ovarian cancer settings that covered cancer vaccines, adoptive T-cell transfer therapy, and immune checkpoint inhibitors during the 14th Annual New Orleans Summer Cancer Meeting.

The FDA has granted an accelerated approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced endometrial cancer who have disease progression following prior systemic therapy. The indication applies to patients who are not candidates for curative surgery or radiation and who have disease that is not microsatellite instability–high or mismatch repair deficient.

To improve the efficacy of chimeric antigen receptor T-cell therapies, Nirali N. Shah, MD, MHSc, suggested including new constructs that target more than 1 antigen in patients with acute lymphoblastic leukemia, during a presentation at the 2019 SOHO Annual Meeting.<br />

Avelumab demonstrated promising efficacy in treating patients with mismatch repair–deficient endometrial cancer, according to the results of a phase II study published in the Journal of Clinical Oncology.

Sarah Ferguson, MD, FRCSC, discusses her experience being involved in a population-based study of women with cervical cancer treated with a radical hysterectomy.

In an interview with Targeted Oncology, Amir A. Jazaeri, MD, discussed the role of LN-145 in cervical cancer. He also highlighted next steps for this treatment approach and the promise of TIL therapy in cervical cancer, as well as other tumor types.

John L. Marshall, MD, spoke with a group of physicians during a Targeted Oncology live case-based peer perspectives discussion on the different classes of agents available to treat patients with gastrointestinal cancers.

Heather Williams, MD provided background on the study of nivolumab as salvage therapy in heavily pretreated patients with gynecologic malignancies in an interview with <em>Targeted Oncology</em>.<strong> </strong>

Krishnansu S. Tewari, MD, discussed the results from the phase III clinical trial investigating the addition of bevacizumab to standard chemotherapy treatment following surgery in patients with advanced ovarian cancer, and the next steps for research regarding the role of bevacizumab in ovarian cancer treatment.

Richard T. Penson, MD, discusses the toxicities that were demonstrated in the long-term follow-up of the phase III SOLO3 trial. This multicenter, open-label trial investigated single-agent olaparib in patients with platinum-sensitive, relapsed, BRCA-mutated ovarian cancer who have received at least 2 prior lines of chemotherapy.


















































