On June 22, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that adds two new products to its portfolio to help improve the management of patients with late-stage and metastatic cancers (Press release, Guardant Health, JUN 22, 2021, View Source [SID1234584240]). The Guardant360 Response test represents a breakthrough as the first commercially available, blood-only, liquid biopsy test that detects changes in circulating tumor DNA (ctDNA) levels to provide oncologists an early indication of a patient’s response to treatment . The Guardant360 TissueNext test, the company’s first tissue-based test, is now available, if needed, to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

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Both products expand on the trusted Guardant360 portfolio to offer oncologists end-to-end testing solutions, covering treatment selection, with the option of ordering tissue biopsy results if needed, and treatment response monitoring, to help improve clinical outcomes for patients with advanced cancer.

The Guardant360 Response liquid biopsy test detects changes in ctDNA levels from a simple blood draw, to assess treatment response up to eight weeks earlier than RECIST (Response Evaluation Criteria in Solid Tumors),1-11 giving oncologists a new tool to use when considering whether to continue, stop, or explore other treatment options for their patients with late-stage or metastatic cancer. Molecular responders (those with decreasing ctDNA levels) show significantly longer progression-free and overall survival rates, compared to molecular non-responders.1-12 In over 50 studies, Guardant Health has demonstrated that molecular response, as measured by changes in ctDNA levels, can help provide an early indication of treatment response across therapies (targeted, immunotherapy, and chemotherapy) and cancer types including non-small cell lung, colorectal, breast, and bladder.1-12

"Using circulating tumor DNA levels to monitor treatment response is a promising new approach in the management of patients with advanced cancer," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "We are delighted to offer oncologists a simple blood test that can provide an early assessment of whether their patient is responding to treatment, or not. Multiple studies using the Guardant360 Response test have shown that molecular response, as measured by circulating tumor DNA levels, can help predict clinical benefit, and longer progression-free survival."

The Guardant360 TissueNext test can now be ordered, alongside the Guardant360 CDx blood test, to prepare for cases when the Guardant360 CDx test does not find actionable biomarkers. While starting with the Guardant360 CDx blood test to perform complete genomic testing finds nearly 80 percent of patients with actionable biomarkers in only seven days,13-15 compared to finding only 50 percent of patients when starting with a tissue biopsy, and which can take two to four times longer,13-15 there are cases when results are needed from a tissue biopsy. The new Guardant360 TissueNext test offers oncologists the most efficient "blood-first, tissue-next" workflow to complete genomic testing, ensuring that as many patients as possible are identified who may benefit from biomarker-informed treatment.

"With the new Guardant360 Response blood test, we are excited to offer a cutting-edge test able to predict patient response to treatment sooner than standard radiographic assessment, to help inform clinical decisions and improve outcomes," said Helmy Eltoukhy, Guardant Health CEO. "By broadening our Guardant360 portfolio to cover not only treatment selection but treatment response, we provide oncologists a more complete view of their patient’s tumor evolution and resistance to interventional therapies, including immunotherapies. Furthermore, while starting with the Guardant360 CDx liquid biopsy for biomarker testing is shown to be more efficient than starting with an invasive tissue biopsy13-15 which has a longer turn-around time to return results, the addition of our new Guardant360 TissueNext test strengthens our treatment selection offering, by providing oncologists the benefits of ‘blood-first, tissue-next’ testing options to find as many patients as possible, who may benefit from biomarker-informed treatment."

The Guardant360 CDx test, the new Guardant360 TissueNext test, and the new Guardant360 Response test are all part of the Guardant360 portfolio, which provides oncologists a more complete genomic picture across the treatment journey. This comprehensive set of cancer tests empowers oncologists to optimize treatment, and know confidently what to do next. From fast treatment selection, starting first with the FDA-approved Guardant360 CDx test, to reflex testing with the Guardant360 TissueNext test, if needed, to early treatment response monitoring with the Guardant360 Response test, the Guardant360 portfolio helps oncologists unlock the full potential of precision oncology for their patients with late-stage and metastatic cancers.

On June 22, 2021 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) along with one of its wholly owned subsidiaries reported that they have reached an agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US (Press release, Sun Pharma, JUN 22, 2021, View Source [SID1234584223]).

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Pursuant to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to USFDA approval) certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals. -All brand names and trademarks are the property of respective owners

On June 22, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a collaboration with Quest Diagnostics (NYSE: DGX) to provide laboratory testing services to Quest patients for its Target Selector NGS-based liquid biopsy targeted lung cancer panel (Press release, Biocept, JUN 22, 2021, View Source [SID1234584241]). Quest Diagnostics is the leading provider of diagnostic information services, including in advanced diagnostics.

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The Biocept Target Selector NGS-based liquid biopsy assay is a less invasive, lab developed test that can be used for genomic profiling in patients with advanced non-small cell lung cancer (NSCLC) to help qualify them for advanced targeted therapies and monitor the effectiveness of treatment. With a physician order, patients will be able to provide a blood specimen for testing at one of Quest’s 2,200 conveniently located patient service centers across the United States. The two parties expect the service to be available to Quest Diagnostics’ providers and patients in the fourth quarter of 2021.

"We are pleased to expand Biocept’s relationship with Quest Diagnostics, as we believe its expertise and reach will allow us to serve more patients and potentially grow our customer base," said Michael Nall, President and CEO of Biocept. "Quest shares our focus on improving care for patients with lung cancer, and this agreement provides a strong collaborator to help us provide oncologists with the answers they need to create more personalized, responsive treatment plans for their patients."

"Lung cancer is one of the most prevalent and deadliest cancers," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. "Better tools to aid in therapy selection and monitoring are urgently needed to improve patient outcomes, which is why we are so excited to work with Biocept on this focused test. Quest has the national scale, oncology expertise and network provider relationships to broaden access to this important innovation in order to potentially improve care for patients in treatment for lung cancer."

Biocept Target Selector NGS-based targeted lung cancer panel includes the most prevalent clinically actionable genes for NSCLC. It combines Biocept’s liquid biopsy biomarker testing expertise with next-generation sequencing and decision support resources. The NGS solution is targeted and actionable—approximately 70% of the biomarkers investigated are based on National Comprehensive Cancer Center guidelines and/or FDA-approved therapies.

On June 22, 2021, United Therapeutics Corporation (the "Company") and Medtronic, Inc. ("Medtronic") reported that agreed to discontinue further efforts to develop and commercialize the Implantable System for Remodulin ("ISR") (Filing, 8-K, United Therapeutics, JUN 23, 2021, View Source [SID1234584280]). By way of background, the ISR has been developed over the past 12 years in collaboration with Medtronic to deliver Remodulin (treprostinil) Injection for patients with pulmonary arterial hypertension ("PAH") via an implantable system developed by Medtronic. On February 25, 2019, Medtronic and the Company entered into a Commercialization Agreement governing the parties’ collaboration to commercialize the ISR in the United States (the "Commercialization Agreement"). Despite approval by the U.S. Food and Drug Administration ("FDA") of Medtronic’s premarket approval application ("PMA") for the ISR in December 2017, commercial launch of the product required Medtronic, as the applicant, to satisfy certain conditions to its PMA approval. Based on the evolution of treatment options and paradigms in PAH over the past few years, and the anticipated efforts required to satisfy the FDA’s conditions of approval, the Company and Medtronic have decided to discontinue further efforts to develop and commercialize the ISR. The Company and Medtronic plan to work together on a mutually-agreed approach to wind-down the development program, and to support patients already enrolled in clinical studies of the ISR, at the Company’s sole expense. Effective June 22, 2021, the parties mutually agreed to terminate the Commercialization Agreement. There were no penalties associated with the termination of the Commercialization Agreement.

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On June 22, 2021 Genmab A/S (Nasdaq: GMAB) reported that the European Commission (EC) has granted marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX SC in the European Union, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis (Press release, Genmab, JUN 22, 2021, View Source [SID1234584224]). The EC also approved DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy. The approvals follow Positive Opinions by the CHMP of the European Medicines Agency in May 2021. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"AL amyloidosis is a potentially fatal blood disorder for which there is no cure, so we are extremely pleased that patients with AL amyloidosis in Europe may soon have a regimen including DARZALEX SC as a treatment option," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are also pleased that, with the approval based on the APOLLO study, the combination of daratumumab with pomalidomide and dexamethasone will now be a treatment option for certain patients with relapsed or refractory multiple myeloma in Europe."

About the ANDROMEDA (AMY3001) study
The Phase 3 study (NCT03201965) included 416 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) or treatment with VCd alone. The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

About the APOLLO (MMY3013) study
The Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous (IV) formulation of daratumumab. As of Amendment 1 to the study protocol, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was progression free survival (PFS). The study was conducted in Europe under an agreement between Janssen, the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

About AL Amyloidosis
Amyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure for AL amyloidosis or existing approved therapies for AL amyloidosis patients in Europe, though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.1 It is estimated that in 2019 there were 4,388 diagnosed incident cases of AL amyloidosis in the five major European markets.2

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.3 Approximately 18,114 new patients were diagnosed with multiple myeloma and approximately 11,063 people died from the disease in the Western Europe in 2020.4 Globally, it was estimated that 176,404 people were diagnosed and 117,077 died from the disease in 2020.5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6

About DARZALEXSC (daratumumab and hyaluronidase-fihj)
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. DARZALEX SC (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved in the Europe for the treatment of both multiple myeloma and AL amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 7,8, 9, 10, 11