Cellectar Biosciences Announces CLR 131 Achieves Primary Efficacy Endpoints from Its Phase 2 CLOVER-1 Study in relapsed/refractory B-cell Lymphomas and Completion of the Phase 1 relapsed/refractory Multiple Myeloma Dose Escalation Study

On February 19, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported positive data from its Phase 2 CLOVER-1 study in patients with relapsed/refractory B-cell lymphomas (Press release, Cellectar Biosciences, FEB 19, 2020, View Source [SID1234554481]). Additionally, the company announced the successful completion of its Phase 1 dose escalation study. Data from the studies demonstrated activity in all indications tested: multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM).

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CLR 131 achieved notable response rates in patients with multiple myeloma – 34.5% overall response rate (ORR) over all therapeutic doses (n=33), and non-Hodgkin’s lymphoma (NHL) – 42% ORR over all doses (n=20) while maintaining a well-tolerated safety profile across all patients. Based upon these positive results and corroborating data showing the potential to further improve upon current overall response rates and durability of those responses, the study has been expanded to test a two-cycle dosing optimization regimen of CLR 131.

Patients in the studies were heavily pre-treated, with multiple myeloma patients having a median of five prior treatment regimens (range: 3 to 17), which included immunomodulatory drugs, proteasome inhibitors and CD38 antibodies for the majority of patients. Additionally, a majority of the patients (51%) were quad refractory or greater and 44% of all treated multiple myeloma patients were triple class refractory. NHL patients in the study were also heavily pre-treated, having had a median of 3 prior lines of treatment (range, 1 to 9) with the majority of patients being refractory to rituximab and/or ibrutinib. In both groups, the patients had a median age of 70 with a range of 51 to 86.

Relapsed/refractory multiple myeloma patients were treated with three different doses (<50mCi, ~50mCi and ~75mCi total body dose (TBD)); the <50mCi total body dose was a deliberately planned sub-therapeutic dose. Patients who received the highest dose of CLR 131 showed a 42.8% ORR, and those who received ~50mCi TBD had a 26.3% ORR with 100% of all evaluable patients (n=43) achieving clinical benefit (primary outcome measure) as defined by having stable disease or better. 85.7% of multiple myeloma patients receiving the higher total body dose levels of CLR 131 experienced tumor reduction. The 75mCi TBD demonstrated positive activity in both high-risk patients and triple class refractory patients with a 50% and 33% ORR, respectively.

"The data reported today are very promising and we believe the product profile for CLR 131 can improve further with the administration of a second cycle. These results are even more impressive considering the challenging patient population tested, as all were heavily pre-treated with the vast majority being refractory to their most recent therapy," said James Caruso, president and CEO of Cellectar Biosciences. "Based upon these compelling data and the need for new and innovative treatment options for patients, we plan to execute upon a well-defined and approvable regulatory path forward in a prioritized hematologic indication. We hope that this potentially first-in-class PLE-targeted radiotherapeutic will provide a new and meaningful treatment option for patients living with multiple myeloma and/or NHL."

The most frequently reported adverse events in relapsed/refractory multiple myeloma patients were cytopenias, which followed a predictable course and timeline. The most common grade ≥3 events at the highest dose (75mCi TBD) were hematologic toxicities including thrombocytopenia (65%), neutropenia (41%), leukopenia (30%), anemia (24%) and lymphopenia (35%). No patients experienced cardiotoxicities, neurological toxicities, infusion site reactions, peripheral neuropathy, allergic reactions, cytokine release syndrome, keratopathy, renal toxicities, or changes in liver enzymes. The safety and tolerability profile in patients with relapsed/refractory NHL was the same except for fewer cytopenias of any grade.

In addition to these findings, subtype assessments were completed in the r/r B-cell NHL patients. Patients with DLBCL demonstrated a 30% response rate with one patient achieving a complete response (CR), which continues at nearly 24 months post-treatment. The response rate for CLL/SLL/MZL patients was 33%. Only two mantle cell patients were enrolled, with stable disease as the best response.

Current data from the company’s Phase 2 CLOVER-1 clinical study show that four LPL/WM patients demonstrated 100% ORR with one patient achieving a complete response which continues at nearly 27 months. This may represent an important improvement in the treatment of relapsed/refractory LPL/WM as no approved or late-stage development treatments for second- and third-line patients have reported a complete response. LPL/WM is a rare, indolent and incurable form of non-Hodgkin’s lymphoma that is comprised of a niche patient population in need of new and better treatment options.

"For patients who have failed the current standard of care treatments for any of these indications, there is a need for additional treatment options," said lead study investigator Sikander Ailawadhi, M.D., Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Jacksonville, Florida. He added, "These data are impressive, especially in these very difficult to treat patient populations. CLR 131 offers a very attractive safety and efficacy profile."

Conference Call Details

The management team will host a conference call for investors today, Wednesday, February 19 at 10:30 am Eastern Time to review the results and data from both the Phase 2 CLOVER-1 study and the Phase 1 r/r MM dose escalation study. The call will also include a presentation from lead investigator, Dr. Sikander Ailawadhi, M.D. Conference call, webcast and post-conference call replay details are as follows:

A webcast replay of the event will be available following the live event on the Events section of the Cellectar website.

About the Phase 2 CLOVER-1 Study

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed/refractory B-cell hematologic cancers. The hematologic cancers being studied include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma/ Waldenstrom’s macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study could enroll up to 80 patients with its primary endpoint being clinical benefit response (CBR), which is defined as the proportion of MM patients within three months following the initial infusion of CLR 131 with stringent complete response, complete response, very good partial response, partial response and stable disease per International Myeloma Working Group criteria, or the proportion of lymphomas patients (CLL/SLL, LPL, MZL, MCL, and DLBCL) within three months following the initial infusion of CLR 131 with CR, PR and SD per the Lugano classification CT-based response criteria. Additional endpoints include overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy. Patients were treated with three different doses (<50mCi, ~50mCi and ~75mCi total body dose) administered in either a single 30-minute infusion or two 30-minute infusions at day 1 and day 7 (± 1), with the option for a second dose cycle approximately 75-180 days later.

Based upon positive results and corroborating data showing the potential to further improve upon the current overall response rates and durability of those responses, the study has been expanded to test a two-cycle dosing optimization regimen of CLR 131. Patients will be administered a two-cycle regimen with a total of four infusions, to be administered on day 1 and day 15 (± 1) and again on day 57 and day 71 (± 1).

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the study. More information about the study, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

About the Phase 1 r/r MM Dose Escalation Study

The Phase 1 multicenter, open-label, dose-escalation study is designed to evaluate the safety and tolerability of CLR 131 administered as a 30-minute I.V. infusion, either as a single bolus dose or as two fractionated doses. The r/r multiple myeloma patients in this study received doses ranging from ≤25mCi to ~75mCi total body dose. To date, an independent Data Monitoring Committee determined that all doses have been safe and well-tolerated by patients.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r DLBCL and Orphan Drug designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

 Bristol-Myers Squibb to Hold Investor Day on April 2

On February 19, 2020 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will hold an Investor Day in New York City on Thursday, April 2, 2020. Giovanni Caforio, M.D., chairman and chief executive officer, and members of the leadership team will discuss the Company’s strategy, pipeline and business opportunities (Press release, Bristol-Myers Squibb, FEB 19, 2020, View Source [SID1234554480]).

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The event will be webcast simultaneously at View Source, with materials related to the presentation available at the start of the live webcast. A replay and archived edition of the presentation will be available following the event.

BAUSCH HEALTH COMPANIES INC. ANNOUNCES FOURTH-QUARTER AND FULL-YEAR 2019 RESULTS AND PROVIDES 2020 GUIDANCE

On February 19, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its fourth-quarter and full-year 2019 financial results (Press release, Bausch Health, FEB 19, 2020, View Source [SID1234554479]).

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"In 2019, we delivered on our ‘pivot to offense’ strategy. Our fourth-quarter and full-year 2019 results demonstrated the consistency and durability of Bausch Health, as we reported our eighth consecutive quarter of organic revenue growth2 and our first full year of reported revenue growth since 2015," said Joseph C. Papa, chairman and CEO, Bausch Health. "The Salix and Bausch + Lomb/International segments are leading our resurgence with continued strong performance."

"During the year, we invested in our future by increasing our commitment to R&D and by deploying approximately $250 million for bolt-on acquisitions to enhance our current product portfolio and add to our development pipeline," Mr. Papa continued.

Company Highlights

Executing on Core Businesses and Advancing Pipeline

The Bausch + Lomb/International segment comprised approximately 55% of the Company’s reported revenue in 2019
___________________________
1 Please see the tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the nearest comparable GAAP measure.
2 Organic growth/change, a non-GAAP metric, is defined as a change on a period-over-period basis in revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations.

Reported revenue in the Bausch + Lomb/International segment increased by 2% in 2019 compared to 2018; revenue in this segment grew organically1,2 by 5% compared to 2018, driven by organic growth1,2 across all five business units

Delivered third consecutive year of organic revenue growth2 in 2019

Launched multiple products in 2019, including:

Ocuvite Eye Performance vitamins

PreserVision AREDS 2 Formula minigel eye vitamins

LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38%

Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses

Zen Multifocal scleral lens for Presbyopia

enVista toric MX60ET intraocular lens

Acquired licensing rights for several investigational products, including:

XIPERE (triamcinolone acetonide suprachoroidal injectable suspension), with a proposed indication of treatment for macular edema associated with uveitis

NOV033 (perfluorohexyloctane), a first-in-class drug with a novel mechanism of action to treat Dry Eye Disease associated with Meibomian gland dysfunction

EM-100, an investigational eye drop that, if approved, will be the first over-the-counter preservative-free eye drop for the treatment of itchy eyes associated with allergies

The Salix segment comprised approximately 23% of the Company’s reported revenue in 2019

Reported revenue in the Salix segment increased by 16% in 2019 compared to 2018

Reported revenue of XIFAXAN (rifaximin) increased by 22% in 2019 compared to 2018

Acquired TRULANCE (plecanatide), a treatment for adults with chronic idiopathic constipation and irritable bowel syndrome with constipation

Acquired dolcanatide, an investigational compound that has demonstrated proof-of-concept in treating patients with multiple gastrointestinal conditions

Entered into a licensing agreement with the University of California, Los Angeles to develop and commercialize a novel investigational compound for the treatment of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis

Acquired licensing rights for MT-1303 (amiselimod), a late-stage investigational sphingosine 1-phosphate (S1P) modulator for the treatment of inflammatory bowel disease, and conducted study to evaluate its cardiovascular safety

The Ortho Dermatologics segment comprised approximately 7% of the Company’s revenue in 2019

Reported revenues in the Global Solta business unit grew by 44% in 2019 compared to 2018, driven by continued strong demand for Thermage FLX system following the launch in the Asia Pacific region

Launched DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, for the topical treatment of plaque psoriasis in adults

Launched a cash-pay prescription program, Dermatology.com, and expanded it to all Walgreens U.S. retail pharmacy locations

Received approval from the U.S. Food and Drug Administration for ARAZLO (tazarotene) Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older; launch is planned for the first half of 2020

Strategic Capital Allocation and Debt Management

Increased Research and Development (R&D) in 2019 by 14%, or $58 million, compared to 2018
____________________________
3 The acquisition of licensing rights for NOV03 was announced in late 2019, and the upfront payment was made in early 2020.

Utilized approximately $1.100 billion in cash generated from operations to repay debt by approximately $900 million and for ‘bolt-on’ acquisitions in 2019

Refinanced $4.240 billion of debt in 2019 to extend maturities and provide flexibility

Raised $1.260 billion of debt in 2019 to fund the settlement of the legacy Valeant U.S. ‘stock drop’ litigation and pay the related financing fees and expenses

Fourth-Quarter and Full-Year 2019 Revenue Performance
Total reported revenues were $2.224 billion for the fourth quarter of 2019, as compared to $2.121 billion in the fourth quarter of 2018, an increase of $103 million, or 5%.

Total reported revenues were $8.601 billion for the full year of 2019, as compared to $8.380 billion for the full year of 2018, an increase of $221 million, or 3%. Excluding the unfavorable impact of foreign exchange of $112 million, the impact of a 2019 acquisition of $55 million and the impact of divestitures and discontinuations of $54 million, revenue grew organically1,2 by approximately 4% compared to the full year of 2018, driven by organic growth1,2 in the Salix and Bausch + Lomb/International segments.

Bausch + Lomb/International segment revenues were $1.238 billion for the fourth quarter of 2019, as compared to $1.205 billion for the fourth quarter of 2018, an increase of $33 million, or 3%. Excluding
___________________________________
4 To assist investors in evaluating the Company’s performance, we have adjusted for changes in foreign currency exchange rates. Change at constant currency, a non-GAAP metric, is determined by comparing 2019 reported amounts adjusted to exclude currency impact, calculated using 2018 monthly average exchange rates, to the actual 2018 reported amounts.

the impact of divestitures and discontinuations of $6 million, the Bausch + Lomb/International segment grew organically1,2 by approximately 3% compared to the fourth quarter of 2018, primarily due to growth in the Global Consumer, Global Surgical and Global Vision Care business units.

Bausch + Lomb/International segment revenues were $4.739 billion for the full year of 2019, as compared to $4.664 billion for the full year of 2018, an increase of $75 million, or 2%. Excluding the unfavorable impact of foreign exchange of $110 million and the impact of divestitures and discontinuations of $41 million, the Bausch + Lomb/International segment grew organically1,2 by 5% compared to the full year of 2018, due to organic growth1,2 across all five business units.

Salix Segment
Salix segment revenues were $517 million for the fourth quarter of 2019, as compared to $426 million for the fourth quarter of 2018, an increase of $91 million, or 21%. The increase was primarily driven by XIFAXAN, which grew 29% as compared to the fourth quarter of 2018.

Salix segment revenues were $2.022 billion for the full year of 2019, as compared to $1.749 billion for the full year of 2018, an increase of $273 million, or 16%. Growth in the segment was primarily driven by higher sales of XIFAXAN, which grew 22% as compared to the full year of 2018, partially offset by the loss of exclusivity of products in the segment, primarily UCERIS (budesonide) and APRISO (mesalamine), which negatively impacted revenues by $96 million.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $158 million for the fourth quarter of 2019, as compared to $160 million for the fourth quarter of 2018, a decrease of $2 million, or 1%. The decline was due to lower volumes primarily driven by the loss of exclusivity of ELIDEL (pimecrolimus) Cream, 1%, ZOVIRAX (acyclovir) Cream, 5%, and SOLODYN (minocycline HCl), partially offset by higher revenues in the Global Solta business unit and revenues from new product launches in the Ortho Dermatologics business unit.

Ortho Dermatologics segment revenues were $565 million for the full year of 2019, as compared to $617 million for the full year of 2018, a decrease of $52 million, or 8%. The decline was due to lower volumes primarily driven by the loss of exclusivity of ELIDEL, ZOVIRAX, SOLODYN and ACANYA (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%, which negatively impacted revenues by $121 million, and was partially offset by higher revenues in the Global Solta business unit and revenues from new product launches in the Ortho Dermatologics business unit.

Diversified Products Segment
Diversified Products segment revenues were $311 million for the fourth quarter of 2019, as compared to $330 million for the fourth quarter of 2018, a decrease of $19 million, or 6%. Diversified Products segment revenues were $1.275 billion for the full year of 2019, as compared to $1.350 billion for the full year of 2018, a decrease of $75 million, or 6%. The decreases in revenue for both the fourth quarter and full year of 2019 were primarily attributed to the previously reported loss of exclusivity for a basket of products.

Operating Results
Operating loss was $1.076 billion for the fourth quarter of 2019, as compared to operating income of $25 million for the fourth quarter of 2018, a decrease of $1.101 billion. The decrease in operating results for the fourth quarter of 2019 was primarily driven by the accrual of legal reserves established

for the resolution of the legacy Valeant U.S. ‘stock drop’ litigation, other related actions and ongoing legacy litigation and investigations, partially offset by lower impairments and increased revenues in the fourth quarter of 2019 versus the fourth quarter of 2018.

Operating loss was $203 million for the full year of 2019, as compared to operating loss of $2.384 billion for the full year of 2018, a favorable change of $2.181 billion. The increase in operating results
primarily reflects goodwill impairment charges recognized in 2018 of $2.322 billion, decreases in the amortization and impairments of intangible assets and increased revenues and gross margins in 2019 versus 2018. The increase in operating results was partially offset by the accrual of legal reserves established for the resolution of the legacy Valeant U.S. ‘stock drop’ litigation, other related actions and ongoing legacy litigation and investigations.

Net Loss
Net loss for the fourth quarter of 2019 was $1.516 billion, as compared to net loss of $344 million for the same period in 2018, an unfavorable change of $1.172 billion. The change is primarily driven by the decrease of $1.101 billion in operating results as discussed above and higher income taxes, partially offset by lower interest expense and debt extinguishment charges.

Net loss for the full year of 2019 was $1.788 billion, as compared to net loss of $4.148 billion for the same period in 2018, a favorable change of $2.360 billion. The change is primarily driven by the increase of $2.181 billion in operating results as discussed above and lower interest expense and debt extinguishment charges.

Adjusted net income (non-GAAP)1 for the fourth quarter of 2019 was $404 million, as compared to $368 million for the fourth quarter of 2018, an increase of $36 million, or 10%.

Adjusted net income (non-GAAP)1 for the full year of 2019 was $1.559 billion, as compared to $1.410 billion for the full year of 2018, an increase of $149 million, or 11%.

Cash Generated from Operations
The Company generated $234 million of cash from operations in the fourth quarter of 2019, as compared to $319 million in the fourth quarter of 2018, a decrease of $85 million, or 27%. The decrease in cash from operations was primarily attributed to the timing of payments and receipts in the ordinary course of business, partially offset by improved operating results.

The Company generated $1.501 billion of cash from operations in 2019, which was in line with 2018.

EPS
GAAP Earnings Per Share (EPS) Diluted for the fourth quarter of 2019 was ($4.30), as compared to ($0.98) for the fourth quarter of 2018. GAAP EPS Diluted for the full year of 2019 was ($5.08), as compared to ($11.81) for the full year of 2018.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $898 million for the fourth quarter of 2019, as compared to $858 million for the fourth quarter of 2018, an increase of $40 million, or 5%.

Adjusted EBITDA (non-GAAP)1 was $3.571 billion for the full year of 2019, as compared to $3.474 billion for the full year of 2018, an increase of $97 million, or 3%. The increase was due to higher

revenues, most notably in the Salix segment, which has favorable gross margins, partially offset by higher operating expenditures to support new product launches and R&D projects.

2020 Financial Outlook
Bausch Health provided guidance for the full year of 2020, as follows:

Full-Year revenues in the range of $8.65 – $8.85 billion

Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.50 – $3.65 billion

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The guidance provided in this section represents forward-looking information and a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

Additional Highlights

Bausch Health’s cash, cash equivalents and restricted cash were $3.244 billion5 at Dec. 31, 2019

The Company’s availability under the Revolving Credit Facility was $1.055 billion at Dec. 31, 2019

Basic weighted average shares outstanding for the fourth quarter of 2019 were 352.6 million shares. Diluted weighted average shares outstanding for the fourth quarter of 2019 were 359.2 million shares6

Basic weighted average shares outstanding for the full year of 2019 were 352.1 million shares. Diluted weighted average shares outstanding for the full year of 2019 were 357.2 million shares6

FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer

On February 19, 2020 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) and granted Priority Review for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing (Press release, Hoffmann-La Roche, FEB 19, 2020, View Source [SID1234554478]). The FDA is expected to make a decision on approval by June 19, 2020.

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"In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible."

This sBLA is based on results from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.595, 95% CI: 0.398–0.890; p=0.0106) in people with high PD-L1 expression (TC3/IC3-WT). Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3–4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.1

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower110 study
IMpower110 is a Phase III, randomised, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-naïve participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations (WT). A total of 572 people (555 WT) were enrolled and were randomised 1:1 to receive:

Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity or death; or
Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).

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, which is 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 is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

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.

Three additional product patents in the US for HyNap-Dasa

On February 18, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) reported that the United States Patent and Trademark Office (USPTO) has granted Xspray three new US patent for HyNap-Dasa (Press release, Xspray, FEB 18, 2020, View Source [SID1234649567]). The new patents, US10,561,643; US 10,561,644; and US10,561,645, are valid until January 2033. This means that Xspray now has seven product patents for the pharmaceutical composition of the company’s primary product candidate, HyNap-Dasa, in the company’s main market USA.
"With a total of seven patents for HyNap-Dasa in our most important market, we can justifiably state that it will be extremely difficult for other players to launch a dasatinib product based on amorphous solid dispersion in the United States during the lifetime of the patent, ie until January 2033. This is undoubtably very important for our potential partners," says Per Andersson, CEO of Xspray.

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Xspray strives to obtain patents for both composition and technology and these new patents claim an amorphous solid dispersion (pharmaceutical composition) of dasatinib.