For Immediate Release

Bayer to Highlight New Research at ASH 2017

New data includes further safety and efficacy follow-up from the CHRONOS-1 study in indolent non-Hodgkin's lymphoma

Abstracts: 1256, 2777, 4042, 4053, 794

WHIPPANY, N.J., Dec. 7, 2017 /PRNewswire/ -- Bayer announced today that the latest findings from its growing body of research in hematologic malignancies for copanlisib and larotrectinib will be presented at the 59th Annual Meeting of the American Society of Hematology (ASH), taking place December 9-12 in Atlanta.

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. (PRNewsfoto/Bayer Corporation)

"At Bayer, our goal is to bring the needs of patients to the forefront of our research and development efforts," said Dario F. Mirski, MD, Senior Vice President and Head of Medical Affairs, Americas. "For patients facing hematologic malignancies that can persist over many years, Bayer is committed to developing potential treatments. At ASH we will present several data sets from clinical trials that demonstrate progress towards serving the unmet needs of patients with hematologic malignancies."

The copanlisib data includes a pharmacodynamic study in patients with non-Hodgkin's lymphoma (NHL) and other diseases, and safety data from a pooled analysis of patients with relapsed indolent NHL. Rounding out the company's ASH lymphoma data are two presentations from the Phase II CHRONOS-1 study: an updated safety and efficacy analysis investigating late-onset severe toxicities and a subset analysis in patients with marginal zone lymphoma (MZL).

Data from this study were published online in the Journal of Clinical Oncology in October 2017. CHRONOS-1 also served as the basis of the recent U.S. Food and Drug Administration (FDA) approval of Aliqopa™ (copanlisib), for the treatment of relapsed follicular lymphoma in adult patients who have received at least two prior systemic therapies.

Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Aliqopa is associated with the following Warnings and Precautions: serious, including fatal, infections, Grade 3 or 4 hyperglycemia, Grade 3 hypertension, non-infectious pneumonitis (NIP), Grade 3 or 4 neutropenia, Grade 3 or 4 cutaneous reactions, and embryo-fetal toxicity. Please see the full Important Safety Information below.

Larotrectinib is an investigational drug that is being developed between Bayer and Loxo Oncology. Larotrectinib has been granted breakthrough therapy designation, rare pediatric disease designation and orphan drug designation (ODD) in the U.S.

See below for the listing of copanlisib and larotrectinib studies to be featured at ASH 2017:

Copanlisib Pharmacodynamic Study

  • Abstract 1256, Session: 605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases: Poster I
    • Date: Saturday, December 9, 2017, Time: 5:30 PM - 7:30 PM
    • Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Copanlisib Safety and Efficacy Studies

  • Abstract 2777, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
    • Updated Safety and Efficacy from the Copanlisib CHRONOS-1 Trial in Patients with Relapsed or Refractory Indolent B-Cell Lymphoma: Low Incidence of Late-Onset Severe Toxicities
    • Date: Sunday, December 10, 2017, Time: 6:00 PM - 8:00 PM
    • Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
  • Abstract 4042, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
    • Pooled Safety Analysis from Phase I and II Studies for Patients with Relapsed Indolent Non-Hodgkin's Lymphoma Treated with Intravenous Copanlisib
    • Date: Monday, December 11, 2017, Time: 6:00 PM - 8:00 PM
    • Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
  • Abstract 4053, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
    • Efficacy of Copanlisib Monotherapy in Patients with Relapsed or Refractory Marginal Zone Lymphoma: Subset Analysis from the CHRONOS-1 Trial
    • Date: Monday, December 11, 2017, Time: 6:00 PM - 8:00 PM
    • Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Larotrectinib Study

  • Abstract 794, Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Novel Therapeutics and Mechanisms of Resistance in Myeloid Disease
    • Characterization of Ntrk fusions and Therapeutic Response to Ntrk Inhibition in Hematologic Malignancies
    • Date: Monday, December 11, 2017, Time: 4:45 PM
    • Location: Georgia World Congress Center, Bldg B, Lvl 2, B207-B208

About Aliqopa (copanlisib)
Aliqopa is an inhibitor of PI3K with inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in FL. Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several key cell-signaling pathways, including B cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines. Aliqopa is administered as a 1-hour intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule. Treatment should be continued until disease progression or unacceptable toxicity.

The broad clinical development program for copanlisib also includes ongoing Phase III studies in indolent NHL (iNHL) patients who have relapsed or are refractory to prior therapies. The CHRONOS-3 Phase III study is evaluating copanlisib in combination with rituximab in relapsed iNHL and the CHRONOS-4 Phase III study is evaluating copanlisib in combination with standard immunochemotherapy in relapsed iNHL. More information about these trials can be found at www.clinicaltrials.gov.

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is an oral and selective investigational drug in clinical development for the treatment of patients across a wide range of cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov or visit www.loxooncologytrials.com. Larotrectinib has not been approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

Important Safety Information

Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection.

Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients treated with ALIQOPA monotherapy. Before initiating treatment with ALIQOPA, consider PJP prophylaxis for populations at risk. Withhold ALIQOPA in patients with suspected PJP infection of any grade. If confirmed, treat infection until resolution, then resume ALIQOPA at previous dose with concomitant PJP prophylaxis.

Hyperglycemia: Grade 3 or 4 hyperglycemia (blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients treated with ALIQOPA monotherapy. Serious hyperglycemic events occurred in 2.8% of patients. Treatment with ALIQOPA may result in infusion-related hyperglycemia. Blood glucose levels typically peaked 5 to 8 hours post-infusion and subsequently declined to baseline levels for a majority of patients; blood glucose levels remained elevated in 17.7% of patients one day after ALIQOPA infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment.

Of the twenty patients with diabetes mellitus treated in CHRONOS-1, seven developed Grade 4 hyperglycemia and two discontinued treatment. Patients with diabetes mellitus should only be treated with ALIQOPA following adequate glucose control and should be monitored closely.

Achieve optimal blood glucose control before starting each ALIQOPA infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hyperglycemia.

Hypertension: Grade 3 hypertension (systolic 160 mmHg or greater or diastolic 100 mmHg or greater) occurred in 26% of 317 patients treated with ALIQOPA monotherapy. Serious hypertensive events occurred in 0.9% of 317 patients. Treatment with ALIQOPA may result in infusion-related hypertension. The mean change of systolic and diastolic BP from baseline to 2 hours post-infusion on Cycle 1 Day 1 was 16.8 mmHg and 7.8 mmHg, respectively. The mean BP started decreasing approximately 2 hours post-infusion; BP remained elevated for 6 to 8 hours after the start of the ALIQOPA infusion. Optimal BP control should be achieved before starting each ALIQOPA infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hypertension.

Non-infectious Pneumonitis: Non-infectious pneumonitis occurred in 5% of 317 patients treated with ALIQOPA monotherapy. Withhold ALIQOPA and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms such as cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam. Patients with pneumonitis thought to be caused by ALIQOPA have been managed by withholding ALIQOPA and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of non-infectious pneumonitis.

Neutropenia: Grade 3 or 4 neutropenia occurred in 24% of 317 patients treated with ALIQOPA monotherapy. Serious neutropenic events occurred in 1.3%. Monitor blood counts at least weekly during treatment with ALIQOPA. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of neutropenia.

Severe Cutaneous Reaction: Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients treated with ALIQOPA monotherapy respectively. Serious cutaneous reaction events were reported in 0.9%. The reported events included dermatitis exfoliative, exfoliative rash, pruritus, and rash (including maculo-papular rash). Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of severe cutaneous reactions.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ALIQOPA can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis caused embryo-fetal death and fetal abnormalities in rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.

Adverse Drug Reactions: Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (≥20%) in ALIQOPA-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%), neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%).

Drug Interactions: Avoid concomitant use with strong CYP3A inducers. Reduce the ALIQOPA dose to 45 mg when concomitantly administered with strong CYP3A inhibitors.

Lactation: Advise women not to breastfeed. Advise a lactating woman not to breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose.

Please see the full Prescribing Information

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes four oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

© 2017 Bayer
BAYER, the Bayer Cross and Aliqopa are registered trademarks of Bayer.

Media Contact:
Rose Talarico, Tel. +1 862.404.5302
E-Mail: rose.talarico@bayer.com

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

  1. AliqopaTM (copanlisib) for injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, September 2017.

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SOURCE Bayer