On May 21, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for DARZALEX▼ (daratumumab) subcutaneous (SC) formulation in two new indications (Press release, Johnson & Johnson, MAY 21, 2021, View Source [SID1234580457]). One recommendation is for the use of daratumumab SC in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd), for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. The second is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adult patients with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated diseases progression on or after the last therapy.

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Both AL amyloidosis and relapsed MM are blood disorders for which unmet treatment needs remain.1,2 AL amyloidosis is a rare and potentially life-threatening disorder that occurs when an insoluble protein called amyloid builds up in tissues and organs, and eventually causes organ deterioration.1,3 The broad and often nonspecific nature of symptoms associated with AL amyloidosis can lead to delays in diagnosis, resulting in organ function deterioration having advanced by the time treatment is initiated for a proportion of patients.4,5 In Europe, there are currently no approved treatments for AL amyloidosis. Without treatment, the average survival rate is 12–18 months, and only around six months for those with severely impaired heart function.6

Multiple myeloma, despite significant treatment advances over the last decade, remains a complex blood cancer to treat, with a particularly challenging area being the management of relapsed or refractory disease. Patient outcomes worsen with each relapse, and the need for effective treatment options becomes crucial.2,7

"Today’s news is an important step forward in enabling us to meet the treatment needs of more patients with these complex blood disorders. Daratumumab has played a significant role in transforming the treatment landscape for multiple myeloma and has now been used to treat nearly 190,000 patients since its first approval in 2016," said Saskia De Haes, Vice President, EMEA Regulatory Affairs, Janssen Pharmaceutica NV. "We look forward to harnessing our expertise to deepen our impact in multiple myeloma and bring transformation to patients with AL amyloidosis, a disease area where the need for innovation is imperative."

The Positive CHMP Opinion for the AL amyloidosis indication is supported by data from the Phase 3 ANDROMEDA study.8 The study evaluated daratumumab SC in combination with VCd, compared with VCd alone, a common treatment regimen used in adult patients with newly diagnosed AL amyloidosis. Patients receiving treatment with daratumumab experienced a significantly higher haematologic complete response rate compared to patients treated with VCd alone (53.3 percent for D-VCd and 18.1 percent for VCd; P<0.0001). Overall, D-VCd had a safety profile consistent with that previously observed for each of the agents alone.7

The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of MM is supported by data from the Phase 3 APOLLO study conducted in collaboration with the European Myeloma Network.9 The study compared D-Pd with Pd alone in 304 patients with relapsed or refractory MM who have received at least one prior treatment regimen with both lenalidomide and a proteasome inhibitor.8 Results show that the addition of daratumumab significantly reduced the risk of progression or death by 37 percent, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval, 0.47-0.85; P=0.0018).8 The median progression-free survival (PFS) for the D-Pd vs. Pd arms was 12.4 vs. 6.9 months, respectively.8 Response rates were significantly higher with D-Pd compared to Pd alone, including rates of overall response (69 percent vs. 46 percent), rates of very good partial response (VGPR) or better (51 percent vs. 20 percent), the rate of complete response (CR) (25 percent vs. 4 percent) and the rate of minimal residual disease-negativity (9 percent vs. 2 percent). The safety profile of D-Pd has been shown to be consistent with known profiles of daratumumab SC and Pd.8

Data from the ANDROMEDA and APOLLO studies were presented most recently during the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting.7,8

"At Janssen, our goal is to improve and prolong patients’ lives as we continue our work to advance oncology science and ultimately deliver cures," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We continually investigate new uses of daratumumab to expand on the ways in which it can deliver benefit to various patient populations."

Both Positive Opinions will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

#ENDS#

About the ANDROMEDA Study10
ANDROMEDA (NCT03201965) is an ongoing Phase 3, randomised, open-label study investigating the safety and efficacy of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd), compared to VCd alone, in the treatment of patients with newly diagnosed light chain (AL) amyloidosis. The study includes 388 patients with newly diagnosed AL amyloidosis with measurable haematologic disease and one or more organs affected. The primary endpoint is overall complete haematologic response rate by intent-to-treat (ITT). Secondary endpoints include major organ deterioration, progression-free survival, major organ deterioration event free survival, organ response rate, overall survival, and time to haematologic response, among others.9

About the APOLLO Study11
APOLLO (NCT03180736) is an ongoing multicentre, Phase 3, randomised, open-label study comparing daratumumab SC, pomalidomide and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression. The study, which was conducted in collaboration with the European Myeloma Network, enrolled 304 participants.10

The primary endpoint is progression-free survival (PFS) between treatment arms. Secondary endpoints include rates of overall response rate (ORR), very good partial response (VGPR) or better, complete response (CR) or better and duration of response, among others. The study reinforces findings from the Phase 1b EQUULEUS (MMY1001) trial, supported the U.S. Food and Drug Administration (FDA) approval of intravenous D-Pd in 2017 for the treatment of relapsed and refractory MM.12 In November 2020, Janssen submitted regulatory applications to the U.S. FDA and European Medicines Agency (EMA) seeking approval of the combination of D-Pd for the treatment of patients with relapsed or refractory MM.10

About daratumumab and daratumumab SC
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab. Since launch, it is estimated that nearly 190,000 patients have been treated with daratumumab worldwide.13 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma (MM). Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.14

CD38 is a surface protein that is highly expressed across MM cells, regardless of the stage of disease. Daratumumab SC binds to CD38 and induces myeloma cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.15

Data across nine Phase 3 clinical trials in the frontline and relapsed settings for MM and newly diagnosed light chain (AL) amyloidosis, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.16,17,18,19,20,21,22,23,24 Additional studies have been designed to assess the efficacy and safety of daratumumab SC in the treatment of other malignant and pre-malignant haematologic diseases in which CD38 is expressed.25

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

About AL Amyloidosis
Light chain (AL) amyloidosis is a rare and potentially fatal haematologic disorder that can affect the function of multiple organs.1,3 The disease occurs when bone marrow produces abnormal antibodies called light chains, which clump together to form a substance called amyloid. These clumps of amyloid are deposited in tissues and vital organs and interfere with normal organ function, eventually causing organ deterioration.1,3 AL amyloidosis is the most common type of systemic amyloidosis.26 It frequently affects the heart, kidneys, digestive tract, liver and nervous system.1,3 Diagnosis is often delayed and prognosis is poor due to advanced, multi-organ, particularly cardiac, involvement. Approximately 30,000 to 45,000 patients in the European Union and the United States have AL amyloidosis.27

About Multiple Myeloma
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.28 In Europe, more than 50,900 people were diagnosed with MM in 2020, and more than 32,500 patients died.29 Around 50 percent of newly diagnosed patients do not reach five-year survival,30,31 and almost 29 percent of patients with MM will die within one year of diagnosis.32

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.2 Relapsed and refractory MM is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.33 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.34 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.5

On May 21, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the Phase 3 RATIONALE 309 trial of its anti-PD-1 antibody tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC) met its primary endpoint of progression-free survival (PFS) at the interim analysis, as recommended by an independent data monitoring committee (Press release, BeiGene, MAY 21, 2021, View Source [SID1234580442]). In the trial results, tislelizumab in combination with chemotherapy demonstrated a statistically significant improvement in PFS in the intention-to-treat (ITT) population when compared to chemotherapy alone, as assessed by an independent review committee (IRC). The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.

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"We are excited to see a clinically meaningful improvement in progression-free survival in our Phase 3 trial for tislelizumab plus chemotherapy in patients with NPC. This is our fifth positive Phase 3 readout for tislelizumab, which we are developing broadly as a potentially differentiated anti-PD-1 antibody," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. "We are grateful for the patients and clinicians who participated in this trial and hopeful that they may have a new treatment option in the future."

BeiGene plans to discuss these data with health authorities and present data at an upcoming medical conference.

RATIONALE 309 Trial of Tislelizumab with Chemotherapy Versus Placebo with Chemotherapy in Recurrent or Metastatic NPC

RATIONALE 309 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT03924986) designed to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC. The trial’s primary endpoint is PFS as assessed by IRC in the ITT population. Key secondary endpoints include overall survival (OS), IRC-assessed objective response rate (ORR) and duration of response (DoR), and investigator-assessed PFS. A total of 263 Asian patients were enrolled and randomized 1:1 to either the tislelizumab plus chemotherapy arm or the placebo plus chemotherapy arm.

About Nasopharyngeal Cancer (NPC)

Nasopharyngeal cancer (NPC) is a malignant, squamous cell carcinoma which arises from the epithelial cells of the nasopharynx, most commonly originating in the pharyngeal recess (the fossa of Rosenmuller).i There were an estimated 60,558 new cases of NPC in China in 2018, accounting for 46.9 percent of the worldwide incidence.ii Despite the heavy public health burden of NPC in southern China and other endemic areas, relatively little is known about the etiology and prevention of NPC.iii The major risk factors for NPC are genetic predisposition, Epstein-Barr virus (EBV) infection, and consumption of salt-preserved food.iv The median overall survival rate is about 20 months in advanced NPCv, however, progressively worsening prognosis falling to a three-year survival of 7-40% were reported in patients with recurrent or metastatic NPC, indicating a high medical unmet needs for more effective treatment.vi,vii,viii

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab market authorization in four indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy; and conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for patients with previously treated unresectable hepatocellular carcinoma.

BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).
BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 80 clinical trials involving more than 13,000 patients. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. The Company currently markets three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis Pharma AG granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On May 21, 2021 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported that updated Phase 2 data from its two clinical programs for bomedemstat (IMG-7289) will be highlighted in e-poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, held online June 9 – 17, 2021 (Press release, Imago BioSciences, MAY 21, 2021, View Source [SID1234580458]).

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2021 EHA (Free EHA Whitepaper) Virtual Congress Presentation Information

Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia
Session Title: Myeloproliferative neoplasms – Clinical
Abstract: EHA (Free EHA Whitepaper)-2504

Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Advanced Myelofibrosis
Session Title: Myeloproliferative neoplasms – Clinical
Abstract: EHA (Free EHA Whitepaper)-2787

The abstracts are available on the EHA (Free EHA Whitepaper) Annual Congress website at www.ehaweb.org/congress. All e-poster presentations will be made available on the EHA (Free EHA Whitepaper) website for on-demand viewing on June 11, 2021.

On May 21, 2021 Exact Sciences Corp. (NASDAQ: EXAS) reported that highlights data from one oral and one poster presentation being featured at the 2021 Digestive Disease Week (DDW) virtual annual meeting, taking place May 21-23(Press release, Exact Sciences, MAY 21, 2021, View Source [SID1234580443]).

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Notably, the poster shares data that incorporate real-world patient adherence rates into a colorectal cancer (CRC) microsimulation model. The data showed that Cologuard (mt-sDNA) was cost effective and provided the greatest reduction in CRC incidence and mortality versus annual fecal immunochemical test (FIT) and annual fecal occult blood test (FOBT) in a representative Medicare population.

Additionally, the oral presentation reports data from the New Hampshire Colonoscopy Registry to compare FIT and Cologuard outcomes in clinical practice. In follow-up colonoscopies performed after a positive stool test result, Cologuard was more likely to predict neoplasia than FIT, largely due to an increased detection of serrated polyps.

Colorectal cancer is the second deadliest cancer impacting both men and women in the U.S. It’s also preventable if caught in early stages when it is more treatable.i The disease has been on the rise in younger adults and approximately 44 million average-risk people in the United States remain unscreened.ii

The abstracts are now available on the DDW website. Included below are titles, abstract numbers, and a summary of each abstract.

Cost-Effectiveness of Stool-Based Colorectal Cancer Screening Using Reported Real-World Adherence Rates in a Medicare Population
Abstract Number: Su053

The impact of real-world adherence rates on the cost-effectiveness of specific CRC screening strategies has been unclear. This study used the CRC-AIM microsimulation modeling platform to estimate the cost-effectiveness of stool-based screening strategies using test-specific, real-world adherence data. The analysis found that Cologuard was cost effective and demonstrated the greatest reduction in CRC incidence and mortality versus FIT and FOBT.

The results from the analysis were also published online in the Journal of Medical Economics.

Comparison of Colonoscopy Findings in Patients with Preceding FIT Positive and mt-sDNA Positive Tests to Patients Having Colonoscopy Only: Data From the New Hampshire Colonoscopy Registry
Abstract Number: 886

There are few comparisons of FIT and Cologuard screening test outcomes in clinical practice. Using the New Hampshire Colonoscopy Registry (NHCR), a comprehensive statewide population-based colonoscopy database, the diagnostic yield of colorectal neoplasia in follow-up colonoscopies in patients with a previous positive FIT, Cologuard, or screening colonoscopy were compared. After follow-up colonoscopy, 1.7% of patients with a positive Cologuard test, 1.6% of patients with positive FIT and 0.3% of patients who underwent screening colonoscopy had adenocarcinoma/colorectal cancer. At follow-up colonoscopy, Cologuard tests were more likely to predict neoplasia than either FIT positivity or screening colonoscopy, largely due to an increased yield of serrated polyps.

On May 21, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 CDx liquid biopsy test as the first and only companion diagnostic for Janssen Biotech, Inc.’s (Janssen’s) RYBREVANT (amivantamab-vmjw) (Press release, Guardant Health, MAY 21, 2021, View Source [SID1234580459]).

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The Guardant360 CDx test will be used for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with RYBREVANT after progressing on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer death in the U.S.1, and NSCLC represents approximately 84 percent of all lung cancers.2 EGFR mutations are present in about one-third of patients with NSCLC,3 and EGFR exon 20 insertion mutations are the third most prevalent mutation type.4 These mutations are highly resistant to chemotherapy and tyrosine kinase inhibitors (TKI)4, and until now, a targeted therapeutic has not existed.

"Today’s FDA approval of Guardant360 CDx as a companion diagnostic for RYBREVANT, the first targeted therapy to treat EGFR exon 20 mutations, is a key milestone for patients who, until now, have had limited treatment options," said Helmy Eltoukhy, Guardant Health CEO. "We are proud to offer our Guardant360 CDx liquid biopsy blood test as a companion diagnostic so that patients may have access to comprehensive genomic profiling in order to see if they are eligible to receive this new treatment."

For oncologists, the FDA-approved Guardant360 CDx provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.