On May 16, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of five ZEJULA (niraparib) abstracts, including two oral presentations, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 1 to June 5, 2018, in Chicago, Illinois (Press release, TESARO, MAY 16, 2018, View Source [SID1234526719]). In addition, TESARO will webcast an investor and analyst briefing on Monday, June 4 at 6:15PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting.

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"TESARO has a targeted clinical development program to assess ZEJULA monotherapy activity in the front-line ovarian cancer setting and in combination with bevacizumab or anti-PD-1 in ovarian, breast and lung cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, we look forward to oral presentations of results from the TOPACIO trial of niraparib plus anti-PD-1 in patients with triple-negative breast cancer or recurrent ovarian cancer, and a poster presentation of data from the QUADRA trial, which evaluated niraparib as a treatment for patients with advanced ovarian cancer."

Please plan to visit TESARO at Booth #10123 to learn more about ZEJULA, TSR-042 (anti-PD-1 antibody), TSR-022 (anti-TIM-3 antibody), and TSR-033 (anti-LAG-3 antibody).

Presentation Details:

Sunday, June 3, 2018, 9:45AM to 11:15AM
TOPACIO/Keynote-162 (NCT02657889): A phase 1/2 study of niraparib + pembrolizumab in patients (pts) with advanced triple-negative breast cancer or recurrent ovarian cancer (ROC): results from ROC cohort.
Oral Presentation; Abstract #106, 10:21AM, Location: Hall D1

Monday, June 4, 2018, 1:15PM to 4:45PM
Cost-effectiveness of niraparib versus routine surveillance, olaparib, and rucaparib for the maintenance treatment of adult patients with ovarian cancer in the United States.
Poster Presentation; Abstract #5559, Poster Board #286, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
OVARIO: The phase 2, single-arm, open-label study of maintenance therapy with niraparib + bevacizumab in patients with advanced ovarian cancer following response on frontline platinum- based chemotherapy.
Poster Presentation; Abstract #TPS5606, Poster Board #330a, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients (pts) with relapsed ovarian cancer (ROC) who have received >3 prior chemotherapy regimens.
Poster Presentation: Abstract #5514, Poster Board #241 Location: Hall A
Poster Discussion: Monday, June 4, 4:45PM – 6:00PM; Location: S100bc

Monday, June 4, 2018, 3:00PM to 4:30PM
TOPACIO/Keynote-162: Niraparib + pembrolizumab in patients (pts) with metastatic triple- negative breast cancer (TNBC), a phase 2 trial.
Oral Presentation; Abstract #1011, 3:36PM, Location: Hall D2

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in Chicago on Monday, June 4th at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting. A reception will begin at 6:00 PM CT, preceding the presentation. During this briefing, TESARO management will provide a business overview and pipeline update and will answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.

On May 16, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that the Company will present on the design of its Phase 1 clinical trial of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Syros Pharmaceuticals, MAY 16, 2018, View Source [SID1234526718]).

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The Phase 1 trial is currently enrolling advanced solid tumor patients in the dose-escalation portion of the trial, with planned expansion cohorts to further evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. Syros expects to open the expansion phase of the trial in mid-2018 and to report data from the dose-escalation portion of the trial in the fourth quarter of 2018.

Details on the presentations are as follows:

Date & Time: Monday, June 4, 8:00 a.m. – 11:30 a.m. CDT
Presentation Title: Trial Design of a First-in-Human Phase 1 Evaluation of SY-1365, a First-in-
Class Selective CDK7 Inhibitor, with Initial Expansions in Ovarian and Breast Cancers
Session Title: Developmental Therapeutics—Clinical Pharmacology and Experimental
Therapeutics
Presenter: Geoffrey Shapiro, M.D., Ph.D., Dana-Farber Cancer Institute
Abstract Number: TPS2600
Location: McCormick Place, Hall A

On May 16, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported detailed results from ADVANCE, a Phase 3 trial of ROLONTIS, demonstrating that it was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of the study (Press release, Spectrum Pharmaceuticals, MAY 16, 2018, View Source [SID1234526717]). ROLONTIS is a novel long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The data released online today in an abstract as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting, also showed similar safety profiles between the treatment groups. The abstract can be find online at View Source

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"These data expand our understanding of the clinical profile of eflapegrastim and help establish it as a possible supportive care treatment option for the multitude of patients undergoing chemotherapy," said Lee Schwartzberg, M.D., FACP, lead investigator, professor of medicine and division chief, hematology oncology, University of Tennessee Health Science Center, and executive director, UT/West Cancer Center. "The study demonstrated strong non-inferiority of ROLONTIS to pegfilgrastim, including a 95 percent confidence interval of the difference in the DSN below zero in the first cycle of treatment, helping further define the clinical profile of this novel treatment."

In the ROLONTIS Phase 3 ADVANCE study (n=406), mean DSN±SD was 0.19±0.478 days for ROLONTIS and 0.34±0.668 days for pegfilgrastim, demonstrating non-inferiority with 95 percent confidence interval (CI) of ∆DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles. There were no statistically significant differences in all secondary endpoints including time to absolute neutrophil count (ANC) recovery, depth of ANC nadir and incidence of febrile neutropenia in Cycle 1. The most common adverse events, which were observed in less than 10 percent of patients, were similar across both treatment groups and were mainly hematologic, including neutropenia, lymphopenia, anemia and leukopenia.

"The ADVANCE study is a cornerstone in the ROLONTIS clinical program, which includes two Phase 3 clinical studies involving approximately 800 patients," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We are pleased that ROLONTIS has shown strong non-inferiority data and comparable safety profile to the current standard of care. ROLONTIS has the potential to be the first novel drug in this multibillion dollar market in more than 15 years."

Spectrum is currently conducting a second Phase 3 ROLONTIS trial, RECOVER, a multi-center study being conducted in the USA, Europe and Asia. The study is fully enrolled and expected to complete later this year. The company plans to conduct a pre-BLA meeting with the FDA in preparation for a planned BLA filing in the fourth quarter of 2018.

About ADVANCE

The ADVANCE study is a Phase 3 multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days for four cycles. Patients were randomized 1:1 to treatment with ROLONTIS or pegfilgrastim (eflapegrastim n=196; pegfilgrastim n=210). The primary study endpoint was the DSN (absolute neutrophil counts [ANC] <0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle. Secondary endpoints included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with stage I to stage IIIA breast cancer were treated on Day 1 of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg) in a 1:1 ratio.

On May 16, 2018 The first positive Phase 1 clinical data assessing cemiplimab as a potiential treatment for advanced non-small cell lung cancer (NSCLC) will be shared at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sanofi Genzyme, MAY 16, 2018, View Source [SID1234526716]). Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1 (programmed cell death protein 1).

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As published online in advance of ASCO (Free ASCO Whitepaper), interim results from the Phase 1 dose-escalation phase and expansion cohort of patients with advanced NSCLC showed that cemiplimab monotherapy resulted in an overall response rate (ORR) of 29 percent (six of 21 patients, all of which were partial responses or non-complete responses or non-progressive disease) and a disease control rate of 57 percent (12 of 21 patients, including ORR and six stable disease or non-complete responses or non-progressive disease) as of the data cut-off date. The duration of response exceeded eight months in five of six patients. In the trial, patients received either a 1 mg/kg dose (one patient) or 200 mg flat dose (20 patients) of cemiplimab, each given every two weeks. The most common treatment-related adverse events were asthenia, pneumonitis and rash (three patients each, 14 percent).

The NSCLC expansion cohort enrolled patients whose disease had worsened after initial improvement (relapsed) or not responded (refractory) after at least one course of chemotherapy. NSCLC patients in the Phase 1 trial had failed, on average, 2.14 previous chemotherapy regimens.

"Cemiplimab is the foundation of our broader immuno-oncology program and the clinical profile we’ve seen to date has encouraged us to explore the potential of this anti-PD-1 in multiple malignancies," said Israel Lowy, M.D., Ph.D, Vice President of Global Clinical Development and Head of Translational Science and Clinical Oncology, Regeneron. "In NSCLC, there remains a high unmet need despite recent advances. The positive Phase 1 results in advanced NSCLC support our strategy to advance cemiplimab in multiple Phase 3 trials exploring a number of treatment settings for this disease."

Cemiplimab being investigated in patients with NSCLC in different settings

The Sanofi and Regeneron clinical development program in NSCLC encompasses several Phase 2 and 3 trials investigating cemiplimab treatment of tumors with different PD-L1 (programmed death-ligand 1) expression levels and as a monotherapy or part of doublet or triplet combinations in the first- and second-line treatment settings. This includes a Phase 3 NSCLC trial investigating cemiplimab combination therapy versus pembrolizumab in certain first-line patients.

"The cemiplimab development program is an example of our ability to rapidly translate scientific innovation into potential treatment breakthroughs in oncology," added Joanne Lager, M.D., Head of Oncology Development, Sanofi. "The data shared at ASCO (Free ASCO Whitepaper) will provide an important foundation for evaluating cemiplimab in new combination regimens, with the goal of helping patients who may not benefit from existing therapies."

Additional results for cemiplimab will also be presented at ASCO (Free ASCO Whitepaper)

In addition to the Phase 1 advanced NSCLC data, updated results from pivotal clinical trials investigating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC) will be presented at ASCO (Free ASCO Whitepaper). Additional accepted abstracts include an assessment of treatment patterns and costs in CSCC as well as overviews of clinical trials in progress for cemiplimab in cervical cancer and for REGN3767, an investigational human monoclonal antibody targeting the immune checkpoint LAG-3 (lymphocyte-activation gene 3), as either a monotherapy or in combination with cemiplimab in solid tumors and lymphoma.

Cemiplimab is currently being reviewed by the U.S. Food and Drug Administration and European Medicines Agency as a potential new treatment for patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery. In addition to CSCC and NSCLC, cemiplimab is also being investigated in potentially pivotal/pivotal trials as a monotherapy for basal cell carcinoma and cervical cancer alongside exploratory trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.

Cemiplimab and REGN3767 are being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Cemiplimab and REGN3767 are currently under clinical development, and their safety and efficacy have not been fully evaluated by any regulatory authority.

On May 16, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the first positive Phase 1 clinical data assessing cemiplimab as a potential treatment for advanced non-small cell lung cancer (NSCLC) will be shared at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Regeneron, MAY 16, 2018, View Source [SID1234526715]). Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1 (programmed cell death protein 1).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As published online in advance of ASCO (Free ASCO Whitepaper), interim results from the Phase 1 dose-escalation phase and expansion cohort of patients with advanced NSCLC showed that cemiplimab monotherapy resulted in an overall response rate (ORR) of 29 percent (six of 21 patients, all of which were partial responses or non-complete responses or non-progressive disease) and a disease control rate of 57 percent (12 of 21 patients, including ORR and six stable disease or non-complete responses or non-progressive disease) as of the data cut-off date. The duration of response exceeded eight months in five of six patients. In the trial, patients received either a 1 mg/kg dose (one patient) or 200 mg flat dose (20 patients) of cemiplimab, each given every two weeks. The most common treatment-related adverse events were asthenia, pneumonitis and rash (three patients each, 14 percent).

The NSCLC expansion cohort enrolled patients whose disease had worsened after initial improvement (relapsed) or not responded (refractory) after at least one course of chemotherapy. NSCLC patients in the Phase 1 trial had failed, on average, 2.14 previous chemotherapy regimens.

"Cemiplimab is the foundation of our broader immuno-oncology program, and the clinical profile we’ve seen to date has encouraged us to explore the potential of this anti-PD-1 in multiple malignancies," said Israel Lowy, M.D., Ph.D., Vice President of Global Clinical Development and Head of Translational Science and Clinical Oncology, Regeneron. "In NSCLC, there remains a high unmet need despite recent advances. The positive Phase 1 results in advanced NSCLC support our strategy to advance cemiplimab in multiple Phase 3 trials exploring a number of treatment settings for this disease."

Cemiplimab being investigated in patients with NSCLC in different settings
The Regeneron and Sanofi clinical development program in NSCLC encompasses several Phase 2 and 3 trials investigating cemiplimab treatment of tumors with different PD-L1 (programmed death-ligand 1) expression levels and as a monotherapy or part of doublet or triplet combinations in the first- and second-line treatment settings. This includes a Phase 3 NSCLC trial investigating cemiplimab combination therapy versus pembrolizumab in certain first-line patients.

"The cemiplimab development program is an example of our ability to rapidly translate scientific innovation into potential treatment breakthroughs in oncology," added Joanne Lager, M.D., Head of Oncology Development, Sanofi. "The data shared at ASCO (Free ASCO Whitepaper) will provide an important foundation for evaluating cemiplimab in new combination regimens, with the goal of helping patients who may not benefit from existing therapies."

Additional results for cemiplimab will also be presented at ASCO (Free ASCO Whitepaper)
In addition to the Phase 1 advanced NSCLC data, updated results from pivotal clinical trials investigating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC) will be presented at ASCO (Free ASCO Whitepaper). Additional accepted abstracts include an assessment of treatment patterns and costs in CSCC as well as overviews of clinical trials in progress for cemiplimab in cervical cancer and for REGN3767, an investigational human monoclonal antibody targeting the immune checkpoint LAG-3 (lymphocyte-activation gene 3), as either a monotherapy or in combination with cemiplimab in solid tumors and lymphoma.

Cemiplimab is currently being reviewed by the U.S. Food and Drug Administration and European Medicines Agency as a potential new treatment for patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery. In addition to CSCC and NSCLC, cemiplimab is also being investigated in potentially pivotal/pivotal trials as a monotherapy for basal cell carcinoma and cervical cancer alongside exploratory trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.

Cemiplimab and REGN3767 are being jointly developed by Regeneron and Sanofi under a global collaboration agreement and were invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully-human antibodies.

Cemiplimab and REGN3767 are currently under clinical development, and their safety and efficacy have not been fully evaluated by any regulatory authority.