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Spectrum Pharmaceuticals Announces Detailed Results from Phase 3 Study of ROLONTIS® (eflapegrastim) Published in an ASCO Abstract

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.

First positive clinical data for cemiplimab in advanced non-small cell lung cancer to be shared at ASCO

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).

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.

Regeneron and Sanofi Share First Positive Clinical Data for Cemiplimab in Advanced Non-small Cell Lung Cancer at ASCO

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).

"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.

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 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.

PharmaCyte Biotech Successfully Completes 29 Tests Conducted on Live Cells Used in Pancreatic Cancer Therapy

On May 16, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the cells it will encapsulate and then use in its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) have successfully passed all 29 tests required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, MAY 16, 2018, View Source [SID1234526714]). Most of the tests were conducted by PharmaCyte’s contractor, Eurofins Lancaster Laboratories, Inc. (Eurofins). The rest of the tests were conducted by third party laboratories subcontracted by Eurofins.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "We are pleased that the cells being used in our LAPC trial have now successfully passed all of the rigorous and extensive testing done on them by Eurofins and its subcontractors. The nature of the various tests was quite varied and some of the tests were more complex than others, so we’re excited that the cells, which are at the heart of our pancreatic cancer therapy, could endure such a wide range of testing and pass each and every one. Now that testing is complete and all results are positive, we have been advised by Eurofins that we will have a final Certificate of Analysis next week. With this document in hand, the cell encapsulation process can begin."

Before any tests could be started, cells from the Master Cell Bank had to be thawed from frozen storage and then cultured to obtain enough cells for all of the planned tests. This was completed on January 24, 2018. In all, the cells underwent 29 different tests. Because of processes involved at Eurofins pertaining to the tests, not all tests could begin at the same time.

Once each test was completed, the test results had to be analysed and a report written by Eurofins. Then the conduct and results of each test had to examined and approved by Eurofins’ Quality Assurance/Quality Control department. Now that all the tests have been successfully completed, Eurofins is preparing the necessary Certificate of Analysis to be sent to Austrianova in Thailand where encapsulation will be performed using PharmaCyte’s signature live-cell encapsulation technology. Having the Certificate of Analysis is a cGMP requirement before encapsulation can begin.

Onxeo Provides Business Update and Reports First Quarter 2018 Financial Information

On May 16, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, notably against rare or resistant forms of cancer, reported its consolidated revenues and cash position at March 31, 2018 (Press release, Onxeo, MAY 16, 2018, View Source [SID1234526713]).

Judith Greciet, Chief Executive Officer of Onxeo, said: "The first quarter of 2018 was highlighted by strong momentum in the development of AsiDNA, our lead product candidate. Following the significant efforts of our R&D team over the previous months, we recently initiated the DRIIV phase I clinical trial in order to evaluate the potential of AsiDNA, our first-in-class DNA repair inhibitor, administered intravenously, in patients with advanced solid tumors. We expect interim data from this study to be available in the second half of 2018. If these results confirm both the safety profile of AsiDNA and its activity, we will have achieved a key milestone in our AsiDNA development program. Importantly, we continue to advance our core R&D programs according to plan while maintaining strict cost control. As such, we expect that our current cash position of €9.2 million will support our currently planned activities until mid-2019, including through multiple potentially value-creating inflection points for our company.