On January 17, 2019 Adaptive Biotechnologies, an immune driven-medicine company, reported that Palmetto GBA, a Medicare Administrative Contractor (MAC) and leader in assessing diagnostic technologies through its MolDX program, has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) (Press release, Adaptive Biotechnologies, JAN 17, 2019, View Source [SID1234532711]). clonoSEQ is the first and only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The Medicare coverage for clonoSEQ is aligned with the assay’s FDA label and with clinical practice guidelines in myeloma and ALL and includes assessing MRD at multiple time points throughout therapy to monitor treatment response and help predict patient outcomes. The article, also posted by the MAC Noridian, is effective immediately and enables national coverage of Medicare patients undergoing clonoSEQ testing.

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"Availability of sensitive, specific and standardized MRD testing is increasingly crucial to the delivery of optimal patient care in both multiple myeloma and ALL," said Nikhil Munshi, M.D., Director of Basic and Correlative Science at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "Medicare coverage for the clonoSEQ Assay will help ensure that eligible patients across the U.S. have access to a highly advanced option for MRD assessment to support more personalized treatment decisions across their course of care."

MRD refers to the remaining number of cancer cells that are present in a patient’s body during and after treatment and may eventually lead to recurrence of the disease. Cancer treatment guidelines for myeloma and ALL call for MRD testing to assess disease burden throughout the course of care to help monitor for remission, detect relapse, determine response to treatment and predict patient outcomes. Controlled trials have shown that even the smallest amounts of residual disease significantly predict a patient’s long-term clinical outcomes.

"This is great news for patients. The establishment of favorable Medicare coverage for clonoSEQ soon after FDA authorization further demonstrates the clinical relevance of MRD assessment and underscores the benefit that this test delivers in the management of myeloma and ALL patients," said Charles Sang, senior vice president, Adaptive Diagnostics. "clonoSEQ is a highly sensitive and standardized MRD test that enables more cost-effective care by assessing the effectiveness of therapy, monitoring remission and identifying relapse in lymphoid blood cancers, serving as a critical tool to help clinicians decide if a patient should initiate, pause or discontinue a potentially costly treatment regimen."

clonoSEQ testing has been used in 25 of the 28 of the National Comprehensive Cancer Network (NCCN) centers in the U.S., and Adaptive is working diligently with community practice leaders to increase use in the community setting. As MRD assessment becomes standard practice for patient management across a range of blood cancers, it is essential that clinicians and patients have access to a highly accurate, sensitive and standardized MRD assessment tool. Having satisfied the analytical and clinical validation requirements of the FDA and met the bar for clinical utility required by Medicare, the clonoSEQ Assay addresses this need.

Adaptive continues to work closely with third-party payers to obtain coverage of clonoSEQ for eligible patients in need. With Medicare coverage in place, Adaptive is strongly positioned to expand commercialization of clonoSEQ in 2019. The company is committed to pursuing regulatory approval for additional potential indications for clonoSEQ in other blood cancers and sample types, including blood-based MRD assessment.

The clonoSEQ coverage decision can be found here.

About the clonoSEQ Assay

The Adaptive Biotechnologies clonoSEQ Assay has been granted De Novo designation by the FDA as an in vitro diagnostic (IVD) to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. It identifies and quantifies specific DNA sequences found in malignant cells, allowing clinicians to monitor patients for changes in disease burden during and after treatment. This robust assay provides sensitive and accurate measurement of residual disease that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers.

clonoSEQ was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk novel devices for which there is no legally marketed predicate device.

For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary

On January 17, 2019 Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly reported that the safety and efficacy data in the gastrectomy patient subgroup of the global Phase III trial TAGS evaluating LONSURF (trifluridine/tipiracil, TAS-102) in patients with metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology (Press release, Servier, JAN 17, 2019, View Source [SID1234532712]). These data were highlighted in an oral presentation at the ASCO (Free ASCO Whitepaper) 2019 Gastrointestinal Cancers Symposium (ASCO-GI) on Thursday 17 January.

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In TAGS, 221 (44%) of the 507 randomized mGC patients had undergone prior gastrectomy (147 LONSURF, 74 placebo), which is reflective of the real-world patient population diagnosed with mGC. The results confirmed that trifluridine/tipiracil prolonged survival versus placebo regardless of prior gastrectomy. The overall results of TAGS demonstrated that patients treated with oral trifluridine/tipiracil showed a clinically meaningful and statistically significant improvement in overall survival (OS) compared with placebo and a 31 percent risk reduction of death (HR 0.69 one sided p=0.00029), which translated into a prolonged median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo).

Additional data investigating trifluridine/tipiracil in metastatic colorectal cancer (mCRC) patients will be presented during a poster session on Saturday 19 January:

Health-related quality of life in the early-access phase IIIb study of trifluridine/tipiracil in pretreated metastatic colorectal cancer (mCRC): Results from PRECONNECT study (abstract 638)
Validation of cost-effectiveness of trifluridine/tipiracil versus best supportive care and regorafenib for previously treated metastatic colorectal cancer in the UK using phase IIIb PRECONNECT early access clinical trial data in the real world setting (abstract 639)
QoL from TASCO1: Health related quality of life of trifluridine/tipiracil-bevacizumab and capecitabine-bevacizumab as first-line treatments in metastatic colorectal cancer patients not eligible for intensive chemotherapy: results from the TASCO1 phase II study (abstract 676)
Trifluridine/tipiracil and regorafenib in patients with metastatic colorectal cancer (mCRC): A single institution retrospective study (abstract 592)
Exploratory analysis of the effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors (abstract 677)
Trifluridine/tipiracil is indicated in European Union for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapies, anti-VEGF agents, and anti-EGFR agents.1 Applications for an additional indication in mGC for LONSURF are currently under review by health authorities in Japan, the United States and the European Union.

About TAGS

TAGS (TAS-102 Gastric Study) is a Taiho-sponsored pivotal Phase III, multinational, randomized, double-blind study evaluating trifluridine/tipiracil, also known as TAS-102, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments. The primary endpoint in the TAGS trial is OS, and the main secondary endpoint measures include progression-free survival (PFS), and safety and tolerability, as well as quality of life.

TAGS enrolled 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The study was conducted in Belarus, the European Union, Israel, Japan, Russia, Turkey and the United States.

For more information on TAGS, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT02500043.

About Metastatic Gastric Cancer

Gastric cancer, also known as stomach cancer, is a disease in which malignant cells form in the lining of the stomach. It is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimated 723,000 deaths annually.2　

When cancer spreads it is called advanced cancer. Locally advanced cancer is when the cancer has grown outside the organ it started in but hasn’t spread to other parts of the body. When the cancer spreads to other parts of the body, this is called metastatic cancer. In the last two decades, the proportion of patients with gastric cancer who present with metastases has risen to over 40%.3

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2-neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, standard third-line treatments are limited.

About Metastatic Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide with approximately 1.4 million new diagnoses in 2012.4 Each year there are over 690,000 deaths making it the fourth biggest cancer killer worldwide (after lung, liver and gastric cancer).5 Those with metastatic disease (where the cancer has spread from the primary site) the average five-year survival is approximately 11%.6 Standard chemotherapy regimens for advanced metastatic colorectal cancer include fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such as those that target vascular endothelial growth factors (VEGF) or endothelial growth factor receptors (EGFR).

Over the last decade, clinical outcomes for patients with mCRC have improved considerably due to the advent of novel treatment agents, predictive biomarkers, and a more strategic approach to the delivery of systemic therapies. Currently, the median overall survival for patients with mCRC being treated both in phase III trials and in large observational series or registries is 30 months – more than double that of 20 years ago.7,8,9

About LONSURF

LONSURF (trifluridine/tipiracil) is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. Trifluridine is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of trifluridine is maintained via tipiracil, which is an inhibitor of the trifluridine-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical Co., Ltd. has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. In the United States, beginning in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside of Japan, Taiho Pharmaceutical’s business partner TTY Biopharm launched LONSURF in Taiwan in July 2018, and Jeil Pharmaceutical is preparing to bring the drug to market in South Korea.

As of December 2018, LONSURF has been approved as a treatment for advanced mCRC in 62 countries and regions worldwide.

On January 17, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that the first patient has been treated in the Phase 1 trial evaluating neoepitopes formulated in the Company’s proprietary DPX delivery platform in patients with ovarian cancer (Press release, IMV, JAN 17, 2019, View Source [SID1234534099]). The study is part of the Company’s DPX-NEO program, which is an ongoing collaboration between UConn Health and IMV to develop neoepitope-based anti-cancer therapies.

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"Expanding our DPX-based clinical immunotherapy program beyond DPX-Survivac is an important milestone for IMV, and we are pleased to be able to do so with this type of cutting-edge program in which the novel mechanism of action underscoring all DPX-based candidates plays a critical role," said Frederic Ors, Chief Executive Officer at IMV. "We believe that the potential of neoepitope-based therapies could be a significant advance in the way physicians treat patients with ovarian cancer who today face a high unmet medical need. We look forward to working with UConn Health to advance this program as IMV is committed to developing an immunotherapy option for women affected by this disease."

Investigators will assess the safety and efficacy of using patient-specific neoepitopes discovered at UConn Health and formulated in IMV’s proprietary DPX-based delivery technology in women with ovarian cancer. Investigators plan to enroll up to 15 patients in the Phase 1 study. UConn Health is funding the trial with IMV providing materials and counsel.

Epitopes are the part of the biological molecule that is the target of an immune response. Neoepitopes are the mutated proteins produced by a patient’s own tumors. Neoepitope immunotherapies target these patient-specific proteins and have been referred to as ‘the next immunotherapy frontier.’ (1)

"The first immunization of the first ovarian cancer patient with our personalized, patient-specific neoepitopes developed at the University of Connecticut using our proprietary technology, formulated in IMV’s excellent immunomodulatory DPX delivery platform, is a major milestone for us," said Study Investigator Pramod K Srivastava, PhD, MD, Director of the Neag Comprehensive Cancer Center at the University of Connecticut School of Medicine.

About the DPX-NEO Program

The DPX-NEO program is an ongoing collaboration evaluating the anti-cancer activity of proprietary patient-specific epitopes developed at UConn Health and formulated in IMV’s DPX-based novel immunotherapeutic delivery technology. IMV had previously announced the results from preclinical research in which researchers at UConn found that neoepitopes formulated in DPX-based

formulations demonstrated superior immunogenic activity over comparators in mouse tumor models. In addition, IMV also previously announced a breakthrough in formulating multiple peptides in DPX formulations. The Company has patented the technology, which allows for both a larger number and a broader potential range of peptides into a single formulation as compared to standard formulation technologies.

On January 17, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) in combination with Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations (Press release, Hoffmann-La Roche, JAN 17, 2019, View Source [SID1234532700]). The FDA is expected to make a decision on approval by 2 September 2019.

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"We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease."

This sBLA is based on results from the Phase III IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with metastatic non-squamous NSCLC.

The FDA recently approved Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. Tecentriq is also approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA approved therapy for NSCLC harbouring these aberrations prior to receiving Tecentriq.

About the IMpower130 study
IMpower130 is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 724 people who were randomised in a 2:1 ratio to receive:

Tecentriq plus nab-paclitaxel and carboplatin (Arm A), or
Nab-paclitaxel and carboplatin (Arm B, control arm)
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People in Arm A received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People in Arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover following disease progression to receive Tecentriq as monotherapy until further disease progression.

The co-primary endpoints were:

PFS as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations, assessed in the ITT-WT population
OS in the ITT-WT population
The IMpower130 study met its OS and PFS co-primary endpoints as per the study protocol. The interim analysis showed that Tecentriq plus chemotherapy helped people live significantly longer compared with chemotherapy alone (median OS=18.6 versus 13.9 months; hazard ratio [HR]=0.79; 95% CI: 0.64–0.98; p=0.033) in the intention-to-treat wild-type (ITT-WT) population.[1] The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (PFS) compared with chemotherapy alone (median PFS=7.0 versus 5.5 months; HR=0.64; 95% CI: 0.54–0.77; p<0.0001) in the ITT-WT population.[1] Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events (AEs) were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared to 60.3% of people receiving chemotherapy alone.

About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[3] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.[3]

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has nine Phase III lung cancer studies evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients

On January 17, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) reported that it has successfully completed the first module of its previously announced research and option agreement with Astellas Pharma Inc. Within the collaboration, the Company is using its Actinium Warhead Enabling (AWE) Platform to conjugate and label select Astellas targeting agents with the potent actinium-225 (Ac-225) payload (Press release, Actinium Pharmaceuticals, JAN 17, 2019, View Source [SID1234532701]).

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"This collaboration represents Actinium and Astellas’ shared commitment to employ cutting-edge technology in the research of new drug candidates for patients. Therefore, we are delighted that Astellas has opted to progress our ground-breaking collaborative research activities to the next stage of research," said Dr. Dale Ludwig, Actinium’s Chief Scientific Officer. "I am very pleased with the results we have generated in our efforts with Astellas to date, which I believe showcase the capabilities of our AWE Platform Technology. My team and I are excited to execute the next module of the collaboration and are optimistic that we will continue to move the program forward."

Since launching its AWE Program in November 2017, Actinium has achieved a number of milestones including:

Appointed Dr. Dale Ludwig, a leading antibody therapeutics and antibody conjugate expert, as Chief Scientific Officer
Presented positive data at ASH (Free ASH Whitepaper) 2017 demonstrating the superior in vitro cell killing properties of Ac-225 labeled daratumumab or Darzalex, Johnson & Johnson’s blockbuster CD38 targeting therapy for multiple myeloma
Presented additional positive data from in vivo animal studies at AACR (Free AACR Whitepaper) 2018 demonstrating enhanced tumor control and survival with Ac-225 labeled daratumumab
Signed collaborative research and option agreement with Astellas
Actinium’s Chairman and Chief Executive Officer Sandesh Seth added, "Actinium’s AWE technology platform encompasses not only our Ac-225 payload but also our intellectual property, know-how, clinical experience, and exoskeleton of a commercial supply chain that uniquely positions us in the industry. The strong execution of this collaboration thus far showcases Actinium’s expanded R&D capabilities that give us great excitement for what we can accomplish in the future with our team and technology. Combined with the continued clinical progress across our pipeline, particularly our pivotal Phase 3 trial for Iomab-B and expansion of our CD33 program into targeted conditioning and new disease indications, we are motivated to capitalize on the significant opportunities that lie ahead of us."

About Actinium Warhead Enabling Platform Technology

The Actinium Warhead Enabling (AWE) Program has at its centerpiece the AWE Platform Technology. The Company’s proprietary AWE Platform Technology is supported by intellectual property and know-how that enables the creation of Actinium-225 (Ac-225) Radio-Conjugates (ARCs) wherein a biomolecular targeting agent is stably labeled with the powerful Ac-225 payload to enhance targeted cell killing. The AWE Platform is protected by intellectual property covering the use of the "gold standard" chelator DOTA, and any conceivable derivative thereof. Additionally, Actinium holds intellectual property protection covering methods of chelation or labeling of the targeting agent with Ac-225, including newer next-generation methodologies for chelation of Ac-225.

The AWE Program is structured to provide the opportunity for partners or collaborators to derive maximum value from a collaboration by leveraging Actinium’s extensive technical know-how, access to its ARC drug development infrastructure and to its underlying AWE Platform Technology. The AWE Program provides a partner or collaborator with access to Actinium’s knowledge bank and infrastructure allowing collaborators to benefit from accelerated development timelines for its ARCs.

To learn more about the AWE Technology Platform or the AWE Program please contact Eileen Geoghegan, Ph.D., at [email protected].