On January 18, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported an update on the Phase 3 RESOLVE trial (PCYC-1137) of ibrutinib (IMBRUVICA) in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma (cancer) (Press release, AbbVie, JAN 18, 2019, View Source [SID1234532785]). Metastatic pancreatic cancer is an aggressive and difficult-to-treat solid tumor primarily treated with chemotherapy today. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. (Janssen). IMBRUVICA has been available in the U.S. since 2013 and is FDA-approved for use in five B-cell blood cancers, as well as in chronic graft-versus-host-disease for a total of nine FDA-approved indications.

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PCYC-1137 evaluated the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with metastatic pancreatic cancer. Patients were randomized 1:1 to receive ibrutinib and nab-paclitaxel and gemcitabine combination treatment arm (n=211 study patients) versus the placebo and nab-paclitaxel and gemcitabine combination treatment arm (n=213 study patients). At conclusion, the study did not meet its primary endpoint of improving progression-free survival (PFS) or overall survival (OS) benefit among the study population. Safety data collected from the study were consistent with the existing safety information for the study therapies. The full results from this trial will be submitted for publication to a future scientific conference and/or a peer-reviewed medical journal.

"We continue to evaluate the potential of IMBRUVICA as a cancer treatment alone or in combination for a variety of cancer types. We are passionately advancing our robust ibrutinib scientific development program to continue to advance cancer standards of care, particularly in areas that have unmet medical need," said Danelle James, M.D., M.A.S., Head of Clinical Science at Pharmacyclics LLC, an AbbVie company.

About the IMBRUVICA (ibrutinib) Clinical Program

IMBRUVICA has a robust clinical oncology development program with more than 130 ongoing clinical trials. IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, more than 135,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.

About the RESOLVE Study (PCYC-1137)

PCYC-1137 is a Pharmacyclics, an AbbVie company, sponsored randomized, multicenter, double-blind, placebo-controlled, Phase 3 study of the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first-line treatment of patients with metastatic pancreatic adenocarcinoma.

About IMBRUVICA

IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.

IMBRUVICA was first approved for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in November 2013.
Soon after, IMBRUVICA was initially approved in adult chronic lymphocytic leukemia (CLL) patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
IMBRUVICA was approved for adult patients with Waldenström’s Macroglobulinemia (WM) in January 2015.
In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with CLL/ small lymphocytic lymphoma (SLL).
In January 2017, IMBRUVICA was approved for adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
In August 2017, IMBRUVICA was approved for adult patients with chronic graft versus host disease (cGVHD) that failed to respond to one or more lines of systemic therapy.
In August 2018, IMBRUVICA plus rituximab was approved for adult patients with WM.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.3 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in 3% of patients, with fatalities occurring in 0.3% of 1,011 patients exposed to IMBRUVICA in clinical trials. Bleeding events of any grade, including bruising and petechiae, occurred in 44% of patients treated with IMBRUVICA.

The mechanism for the bleeding events is not well understood.

IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 24% of 1,011 patients exposed to IMBRUVICA in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (23%), thrombocytopenia (8%), and anemia (3%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA.

Monitor complete blood counts monthly.

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA therapy. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients, and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4% of 1,011 patients exposed to IMBRUVICA in clinical trials. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.

Periodically monitor patients clinically for cardiac arrhythmias. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias appropriately, and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension: Hypertension has occurred in 12% of 1,011 patients treated with IMBRUVICA in clinical trials with a median time to onset of 5 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA. Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive treatment as appropriate.

Second Primary Malignancies: Other malignancies (9%) including non-skin carcinomas (2%) have occurred in 1,011 patients treated with IMBRUVICA in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.

Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (58%)*, neutropenia (58%)*, diarrhea (42%), anemia (39%)*, rash (31%), musculoskeletal pain (31%), bruising (31%), nausea (28%), fatigue (27%), hemorrhage (23%), and pyrexia (20%).

The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (36%)*, thrombocytopenia (15%)*, and pneumonia (10%).

Approximately 6% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, stomatitis (29%), muscle spasms (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).

The most common Grade 3 or 4 adverse reactions (≥5%) reported in patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia (10%)*, pneumonia (10%), sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

*Treatment-emergent decreases (all grades) were based on laboratory measurements and adverse reactions.

DRUG INTERACTIONS

CYP3A Inhibitors: Dose adjustments may be recommended.

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA dose.

On January 18, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its fourth quarter and full year 2018 financial and operating results on Wednesday, February 6, 2019, before the U.S. financial markets open (Press release, Regeneron, JAN 18, 2019, https://www.prnewswire.com/news-releases/regeneron-to-report-fourth-quarter-and-full-year-2018-financial-and-operating-results-and-host-conference-call-and-webcast-on-february-6-2019-300781040.html [SID1234532786]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days

On January 18, 2019, Bristol-Myers Squibb Company ("Bristol-Myers Squibb") reported that it has entered into a Term Loan Agreement (the "Term Loan Agreement") with the lenders party thereto and Morgan Stanley Senior Funding, Inc., as administrative agent (Filing, 8-K, Bristol-Myers Squibb, JAN 18, 2019, View Source [SID1234532805]). The Term Loan Agreement provides for total term loan commitments in an aggregate principal amount of $8.0 billion and reduces the $33.5 bridge facility commitments previously described in the Current Report on Form 8-K filed by Bristol-Myers Squibb with the Securities and Exchange Commission (the "SEC") on January 4, 2019 (the "January 4 Current Report") by such principal amount. The Term Loan Agreement was entered into in connection with the previously announced proposed merger (the "Merger") of a wholly owned subsidiary of Bristol-Myers Squibb with Celgene Corporation ("Celgene"), pursuant to the Agreement and Plan of Merger, dated as of January 2, 2019 (the "Merger Agreement"), among Bristol-Myers Squibb, Celgene and Burgundy Merger Sub, Inc., a wholly-owned subsidiary of Bristol-Myers Squibb, described in the January 4 Current Report.

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The lenders party to the Term Loan Agreement will be obligated to make loans under the Term Loan Agreement upon the satisfaction or waiver of several limited conditions, including but not limited to completion of the Merger, the non-occurrence of a material adverse effect (as such term is defined in the Term Loan Agreement) on Celgene, the accuracy in all material respects of certain representations and warranties related to both Bristol-Myers Squibb and Celgene, the absence of certain defaults by Bristol-Myers Squibb, the delivery of certain financial statements of Bristol-Myers Squibb and Celgene and other customary conditions to completion more fully set forth in the Term Loan Agreement. The date such limited conditions are satisfied or are waived in accordance with the terms of the Term Loan Credit Agreement and the loans thereunder are funded is referred to herein as the "Closing Date."

The term loan facility under the Term Loan Agreement consists of a $1 billion 364-day tranche, a $4 billion three-year tranche and a $3 billion five-year tranche. Borrowings under the Term Loan Agreement will be unsecured. The term loans are pre-payable without premium or penalty (but subject to breakage costs, if applicable). The term loans under the $1 billion 364-day and the $4 billion three-year tranche do not amortize. The five-year tranche amortizes in equal quarterly amounts equal to (i) 0.0% from after the Closing Date to, and including, the third anniversary of the Closing Date and (ii) 10% per annum from after the third anniversary to, and including, the five-year anniversary of the Closing Date. The $1 billion tranche of the term loan facility will mature and be payable on the 364-day anniversary of the Closing Date. The $4 billion tranche of the term loan facility will mature and be payable on the third anniversary of the Closing Date. The $3 billion tranche of the term loan facility will mature and be payable (to the extent not amortized) on the fifth anniversary of the Closing Date.

At the option of Bristol-Myers Squibb, borrowings under the Term Loan Agreement will bear interest at either a base rate or at the Eurodollar rate, plus, in each case, an applicable margin. The applicable margin will range from (i) with respect to the $1 billion 364-day tranche, 0.0 – 0.125% with respect to base rate borrowings, and 0.75 – 1.125% with respect to Eurodollar rate borrowings, (ii) with respect to the $4 billion three-year tranche, 0.0 – 0.25% with respect to base rate borrowings, and 0.875 – 1.25% with respect to Eurodollar rate borrowings, and (iii) with respect to the $3 billion five-year tranche, 0.0 – 0.375% with respect to base rate borrowings, and 1.00 – 1.375% with respect to Eurodollar rate borrowings in each case, based on the public ratings of Bristol-Myers Squibb’s non-credit enhanced senior unsecured long-term debt, as set forth in the Term Loan Agreement. The base rate will be, for any day, a fluctuating rate per annum equal to the highest of (i) the rate last quoted by The Wall Street Journal as the "Prime Lending Rate" (if more than one rate is published as the Prime Lending Rate, then the highest of such rates), (ii) the Federal Funds effective rate plus 0.5% and (iii) the one-month reserve adjusted Eurodollar Rate plus 1% (provided, that the reserve adjusted Eurodollar Rate shall not be less than zero). The Eurodollar rate will be an annual rate equal to the London Interbank Offered Rate. Pursuant to the base rate option, interest will be calculated on the basis of the actual number of days elapsed in a year of 365 or 366 days and will be payable quarterly in arrears. Alternatively, under the Eurodollar rate option, interest will be determined based on interest periods to be selected by Bristol-Myers Squibb of one, two, three or six months, will be calculated on the basis of the actual number of days elapsed in a year of 360 days and will be payable at the end of each interest period (and at the end of every three months, in the case of interest periods longer than three months).

The Term Loan Agreement contains certain covenants relating to the following subjects: legal existence; business and properties; delivery of financial statements, reports, etc.; maintenance of insurance; obligations and payment of taxes; litigation and other notices; books and records; maintenance of ratings; compliance with laws; limitations on mergers, sales of assets and consolidations; limitations on liens; limitations on sale and leaseback transactions; and sanctions, anti-corruption laws and guaranties.

The Term Loan Agreement also contains certain events of default, limited to nonpayment of principal when due; nonpayment of interest, fees or other amounts after a three business day grace period; material inaccuracy of representations and warranties; violation of covenants (subject, in the case of certain affirmative covenants, to certain grace periods); cross-payment default and cross-acceleration; bankruptcy events; material judgments; change of control; certain ERISA events; and to the extent there are any guarantees of the term facility then in effect, actual or asserted invalidity of such guarantees under the Term Loan Agreement.

The description of the Term Loan Agreement contained in this item 1.01 does not purport to be complete and is qualified in its entirety by reference to the full text of the Term Loan Agreement, a copy of which is filed hereto as Exhibit 10.1 to this Current Report on Form 8-K, and the terms of which are incorporated herein by reference.
The representations, warranties and covenants contained in the Term Loan Agreement were made only for purposes of such agreement and as of the dates specified therein, were solely for the benefit of the parties thereto and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of Bristol-Myers Squibb and its subsidiaries. Moreover, information concerning the subject matter of any representations, warranties and covenants may change after the dates of the Term Loan Agreement, which subsequent information may or may not be fully reflected in public disclosures by Bristol-Myers Squibb.

Certain of the financial institutions party to the Term Loan Agreement, either directly or through affiliates, have performed, and may in the future perform, various commercial banking, investment banking and other financial advisory services in the ordinary course of business for Bristol-Myers Squibb and in connection with the Merger for which they have received, and will receive, customary fees and commissions.

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