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CTI BioPharma Announces Publication of Article Highlighting Pacritinib Data from the PAC203 Phase 2 Study in Myelofibrosis in Blood Advances

On November 30, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported that an article highlighting pacritinib data was published in Blood Advances (Press release, CTI BioPharma, NOV 30, 2020, View Source [SID1234572006]). The article, titled "Determining the Recommended Dose of Pacritinib: Results from the PAC203 Phase 2 Dose-Finding Study in Patients with Advanced Myelofibrosis" is available online via this link.

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"Having recently announced the start of a rolling NDA submission for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia, a patient population with reduced survival and limited therapeutic options, we continue to be committed to adding to the growing body of evidence underscoring the efficacy and safety profile of pacritinib," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "As our application will consist of a data package from the PERSIST-1, PERSIST-2 and PAC203 Phase 2 trials, with the ongoing Phase 3 PACIFICA trial expected to be completed as a post-marketing commitment, the data published today support our belief that pacritinib has the potential to become an important treatment in this disease setting, pending regulatory approval."

PAC203 Phase 2 was an open-label, randomized, dose-finding trial of pacritinib in patients with myelofibrosis who were previously treated with ruxolitinib. Patients were randomized 1:1:1 to pacritinib 100 mg daily (QD), 100 mg BID, or 200 mg BID. The trial demonstrated that pacritinib 200 mg BID had a favorable benefit risk profile. Spleen volume response (SVR) rates were highest among patients treated with pacritinib 200 mg BID who had a baseline platelet count of less than 50 x 109/L. Overall, the study data supported the selection of the pacritinib 200 mg BID for use in the ongoing Phase 3 PACIFICA study of pacritinib in patients with myelofibrosis with severe thrombocytopenia.

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

Regeneron Announces Investor Webcast at American Society of Hematology 2020 Annual Meeting

On November 30, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will host a webcast on Monday, December 7, 2020 at 4:30pm EST (Press release, Regeneron, NOV 30, 2020, View Source [SID1234572005]). Management will discuss data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting as well as provide updates on the Company’s broader oncology and hematology portfolio.

Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7442859. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

Ipsen receives FDA Fast Track designation for investigational irinotecan liposome injection (ONIVYDE®) as a second-line monotherapy treatment for small cell lung cancer (SCLC)

Thermo Fisher Scientific to Present at the Evercore ISI HealthCONx Conference on December 1, 2020

On November 30, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, chairman, president and chief executive officer, will present virtually at the Evercore ISI HealthCONx Conference on Tuesday, December 1, 2020, at 1:00 p.m. (EST) (Press release, Thermo Fisher Scientific, NOV 30, 2020, https://www.prnewswire.com/news-releases/thermo-fisher-scientific-to-present-at-the-evercore-isi-healthconx-conference-on-december-1-2020-301181393.html [SID1234572004]). Among other topics, Mr. Casper will provide the company’s current perspective on the impact of the COVID-19 pandemic and expectations for future financial performance.

You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com.

New Publication from I-SPY 2 Trial Highlights Signatera’s Ability to Predict Treatment Outcomes in Neoadjuvant Breast Cancer Patients

On November 30, 2020 Natera,Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported a new paper published in Annals of Oncology, highlighting the use of its personalized and tumor-informed circulating tumor DNA (ctDNA) assay, Signatera, in monitoring the response to neoadjuvant chemotherapy (NAC) across all breast cancer subtypes (Press release, Natera, NOV 30, 2020, View Source [SID1234572003]). The manuscript can be found here.

Roughly 275,000 patients are diagnosed with breast cancer every year,1 and many receive NAC — the preoperative treatment of cancer with chemotherapy, radiation therapy, or endocrine therapy — which has become a standard of care for patients with locally advanced breast cancer. The primary goal of NAC is to downstage the tumor and allow for breast conserving surgery in those whose tumors are responsive to treatment. However, according to the National Comprehensive Cancer Network’s clinical practice guidelines,2 "the accurate assessment of in-breast tumor or regional lymph node response to preoperative systemic therapy is difficult."

Furthermore, a minority of patients receiving NAC achieve pathologic complete response (pCR), which occurs when there are no discernable tumor cells in the surgically resected tissue after NAC. These patients are known to enjoy very low risk of metastatic recurrence3 and may avoid additional treatment after surgery. In fact, the FDA considers pCR as a surrogate endpoint for drug efficacy. Among non-pCR patients, however, studies show that 20-25% will experience metastatic recurrence.3 Since there are currently no accurate biomarkers available for further risk stratification, most non-pCR patients receive additional systemic therapy after surgery.

"The I-SPY 2 Trial was designed to use novel biomarkers to help accelerate drug development and improve clinical outcomes," said Laura Esserman, MD, MBA, and Laura van ‘t Veer, PhD, breast cancer specialists, professors at the University of California San Francisco, and co-authors of the paper. "This study shows that personalized ctDNA monitoring is a powerful new tool that can help evaluate novel therapies faster, in conjunction with other biomarkers like pCR and MRI imaging response. This technology may also help guide clinical decisions in the neoadjuvant setting, including the type and timing of surgery and whether to switch treatment modalities."

The study analyzed 291 plasma samples from 84 patients who received neoadjuvant treatment. Serial blood samples were collected before treatment (T0), during treatment (T1, T2), and after treatment but before surgery (T3), with detailed clinical outcomes collected up to 6 years post-surgery. Key findings from the study include:

Early clearance of ctDNA during treatment (at T1) was significantly associated with the increased likelihood of achieving pCR (P = 0.012)
Among the 43 patients who did not achieve pCR, 86% were ctDNA-negative after NAC (T3) and achieved distant relapse-free survival of 93%, almost the same as those who achieved pCR
Among those patients who were ctDNA-positive after NAC (T3), 67% experienced metastatic recurrence
"Breast cancer patients who achieve pCR after NAC have been shown to enjoy a significant survival advantage over those who do not," said Alexey Aleshin, MD, MBA, Natera’s Senior Medical Director of Oncology. "However, predicting early metastatic recurrence in patients who do not achieve pCR remains a significant unmet need. Our study shows that Signatera can be used to monitor the response to NAC in real time, potentially allowing physicians to switch treatments or move to surgery earlier. Signatera may also improve on pCR as a prognostic marker for survival, which may have profound effects on how patients are treated in the adjuvant setting."

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.