On September 16, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into a worldwide license agreement with Menlo Park, CA-based TeneoBio, Inc (Press release, Ligand, SEP 16, 2016, View Source [SID:SID1234515191]). Under the license, TeneoBio will be able to use the OmniFlic technology from the OmniAb platform to discover fully human bispecific antibodies to be developed for the treatment of various diseases, with an initial focus on therapeutics for cancer, autoimmunity, and infectious diseases. Ligand is eligible to receive annual platform access payments, sublicensing fees, milestone payments and royalties for products incorporating an OmniFlic antibody. TeneoBio will be responsible for all costs related to the programs.

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"Ligand continues to increase its portfolio of partners and fully funded drug research programs. Similar to our Captisol acquisition years ago, our OmniAb business is proving to be a valuable platform for new deal making," said John Higgins, Chief Executive Officer of Ligand. "These follow-on licensing deals post acquisition are important as we are able to expand our programs from which we are entitled to receive potential future economics without increasing our operating costs or diluting our capital structure."

"We are delighted with our partnership with Ligand," said Wim van Schooten, Chief Scientific Officer of TeneoBio. "OmniFlic platform access will enable TeneoBio to discover novel antibody sequences that perfectly complement our UniAb technology. We are familiar with the range of technology offerings in the field, and believe OmniAb is an industry-leading platform for the efficient generation of fully-human antibodies. We look forward to further leveraging our unique discovery engine to develop therapeutic antibodies at unprecedented speeds."

On September 16, 2016 Takeda Pharmaceutical Company Limited (TSE: 4502) reported today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the conditional approval of NINLAROTM (ixazomib) capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (Press release, Takeda, SEP 16, 2016, View Source [SID:SID1234515190]). If the European Commission ratifies the CHMP’s opinion and authorization is granted, NINLARO will be the first and only oral proteasome inhibitor approved for use across the European Economic Area, which includes the 28 member states of the European Union as well as Norway, Liechtenstein and Iceland.

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"This is great news and a very positive development for myeloma patients in Europe," said Eric Low, Chief Executive, Myeloma UK, and Board Member, Myeloma Patients Europe. "The improvement in progression free survival in this difficult-to-treat stage of myeloma is significant. In addition to ixazomib’s efficacy in this relapsed and/or refractory group of patients, its manageable safety profile and oral administration makes ixazomib a very welcome new treatment option for this serious and complex cancer. It is important that attention is now turned in earnest to the Health Technology Assessment bodies to ensure their approval of ixazomib.’’

Data from the pivotal Phase 3 trial TOURMALINE-MM1 demonstrate that the addition of NINLARO to lenalidomide and dexamethasone provides a significant improvement in progression-free survival when compared to placebo plus lenalidomide and dexamethasone in this patient population. Patients continue to be treated to progression in the trial, with additional evaluations planned for long-term outcomes such as overall survival.

"The heterogeneity of multiple myeloma means that it is very important for patients and physicians to have access to a variety of treatment options, and many physicians are now looking forward to the possibility of adding NINLARO to our treatment armamentarium," said Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes, France. "The clinical data strongly support the use of NINLARO in relapsed and/or refractory patients, while also delivering the advantages of an all-oral triplet regimen. In the TOURMALINE-MM1 trial, the NINLARO regimen showed a significant improvement in progression-free survival of 35 percent when compared to the placebo regimen."

"Today’s positive CHMP opinion for the conditional approval of NINLARO is an important first step to bringing this treatment to a relapsed and/or refractory patient population where there is a significant unmet need," said Christophe Bianchi, M.D., President, Takeda Oncology. "Currently approved proteasome inhibitors are only available through twice-weekly injections and infusions, which can place additional logistical burdens on patients and their caregivers, who already are dealing with a difficult disease. We hope that the efficacy, convenience and manageable safety profile of this innovative treatment may allow for extended duration of treatment, which has the potential to improve patient outcomes. Thank you to the patients and investigators for their participation in the TOURMALINE-MM1 trial to further our understanding of NINLARO’s benefits."

For a conditional approval, Takeda is required to provide post-approval updates on safety and efficacy analyses for TOURMALINE-MM1 and some other already ongoing studies to demonstrate the treatment’s long-term effects.

NINLARO received its first approval from the U.S. Food and Drug Administration in November 2015 following priority review. In the U.S., it is indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Currently licensed for use in the U.S., Canada, Israel and Venezuela, NINLARO is also under review for approval by a number of regulatory authorities around the world. The CHMP’s positive opinion for the conditional approval of NINLARO will now be reviewed by the European Commission.

About Multiple Myeloma

Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with approximately 39,000 new cases in the EU and 114,000 new cases globally per year.

About NINLAROTM (ixazomib)
NINLAROTM (ixazomib) is an oral proteasome inhibitor, which is being studied in multiple myeloma and systemic light-chain (AL) amyloidosis. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval in the countries listed above.

Ixazomib was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.

The comprehensive ixazomib clinical development program, TOURMALINE, further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. TOURMALINE includes a total of five ongoing pivotal trials – four investigating every major multiple myeloma patient population and one in light-chain amyloidosis:

TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
In addition to the TOURMALINE program, Takeda supports a number of investigator initiated studies evaluating the use of ixazomib in various combinations in oncology settings for patients globally.

NINLAROTM (ixazomib): Global Important Safety Information

SPECIAL WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO (28% vs. 14% in the NINLARO and placebo regimens, respectively) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. It did not result in an increase in hemorrhagic events or platelet transfusions. Monitor platelet counts at least monthly during treatment with NINLARO and consider more frequent monitoring during the first three cycles. Manage with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal toxicities have been reported in the NINLARO and placebo regimens respectively, such as diarrhea (42% vs. 36%), constipation (34% vs. 25%), nausea (26% vs. 21%), and vomiting (22% vs. 11%), occasionally requiring use of antiemetic and anti-diarrheal medications, and supportive care.

Peripheral neuropathy was reported with NINLARO (28% vs. 21% in the NINLARO and placebo regimens, respectively). The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

Peripheral edema was reported with NINLARO (25% vs. 18% in the NINLARO and placebo regimens, respectively). Evaluate patients for underlying causes and provide supportive care, as necessary. Adjust the dose of dexamethasone per its prescribing information or the dose of NINLARO for severe symptoms.

Cutaneous reactions occurred in 19% of patients in the NINLARO regimen compared to 11% of patients in the placebo regimen. The most common type of rash reported in both regimens was maculo-papular and macular rash. Manage rash with supportive care, dose modification or discontinuation.

Hepatotoxicity, drug-induced liver injury, hepatocellular injury, hepatic steatosis, and hepatitis cholestatic have been uncommonly reported with NINLARO. Monitor hepatic enzymes regularly and adjust dose for Grade 3 or 4 symptoms.

Pregnancy- NINLARO can cause fetal harm. Advise male and females patients of reproductive potential to use contraceptive measures during treatment and for an additional 90 days after the final dose of NINLARO. Women of childbearing potential should avoid becoming pregnant while taking NINLARO due to potential hazard to the fetus. Women using hormonal contraceptives should use an additional barrier method of contraception.

Lactation- It is not known whether NINLARO or its metabolites are excreted in human milk. There could be potential adverse events in nursing infants and therefore breastfeeding should be discontinued.

SPECIAL PATIENT POPULATIONS

Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis. NINLARO is not dialyzable and, therefore, can be administered without regard to the timing of dialysis.

DRUG INTERACTIONS

Co-administration of strong CYP3A inducers with NINLARO is not recommended.

ADVERSE REACTIONS

The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen, and greater than in the placebo regimen, were diarrhea (42% vs. 36%), constipation (34% vs. 25%), thrombocytopenia (28% vs. 14%), peripheral neuropathy (28% vs. 21%), nausea (26% vs. 21%), peripheral edema (25% vs. 18%), vomiting (22% vs. 11%), and back pain (21% vs. 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.

For US Prescribing Information: View Source

For Canada Product Monograph: View Source

On September 16, 2016 Pfizer Inc. (NYSE:PFE) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that IBRANCE (palbociclib) be granted marketing authorization in the European Union (EU) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer (Press release, Pfizer, SEP 16, 2016, View Source [SID:SID1234515189]). The CHMP’s positive opinion is for IBRANCE to be used in combination with an aromatase inhibitor, as well as in combination with fulvestrant in women who have received prior endocrine therapy. The CHMP’s opinion will now be reviewed by the European Commission (EC).

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If approved, IBRANCE would be the first medicine in a new class of anti-cancer treatments, cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors, to be approved by the EC.

"Today’s opinion by the CHMP to recommend marketing authorization of IBRANCE in the EU is an important step toward expanding treatment options for women in Europe with HR+/HER2- metastatic breast cancer, and a step toward a potential new standard of care for this cancer," said Mace Rothenberg, M.D., chief development officer, Pfizer Oncology. "The opinion is supported by robust data with consistent results observed across three separate randomized trials in which the addition of IBRANCE to standard endocrine therapy resulted in significant prolongation of progression-free survival compared to endocrine therapy alone."

"There have been only modest improvements in the prognosis of patients with metastatic breast cancer in Europe over the past three decades, underscoring the need for new treatment advances," said Andreas Penk, M.D., regional president, International Developed Markets, Pfizer Oncology. "We look forward to working with the EC as they conduct their review, with the goal of bringing this first-in-class medicine to appropriate patients across the EU."

Breast cancer is the most common invasive cancer among women in Europe, with more than 464,200 new cases and 131,260 deaths per year.1 Up to 30 percent of women diagnosed with and treated for early breast cancer will go on to develop metastatic breast cancer,2,3 which occurs when the cancer spreads beyond the breast to other parts of the body.4 There is no cure for metastatic breast cancer,5 and patients are in need of new treatment options that help keep their cancer from worsening, manage symptoms and help them maintain quality of life for as long as possible.2,4

Pfizer announced last year that the EMA validated for review the Marketing Authorization Application (MAA) for IBRANCE, which was submitted based on final results from the Phase 2 PALOMA-1 and Phase 3 PALOMA-3 trials. These studies demonstrated that IBRANCE in combination with an endocrine therapy improved progression-free survival (PFS) compared to the endocrine therapy alone or with placebo in certain patients with HR+/HER2- metastatic breast cancer. Results from a separate Phase 3 trial, PALOMA-2, conducted in the same patient population as the Phase 2 PALOMA-1 trial, also demonstrated an improvement in PFS and were added during the MAA review.

About IBRANCE (palbociclib)

IBRANCE is an oral inhibitor of cyclin dependent kinases (CDKs) 4 and 6,6 which are key regulators of the cell cycle that trigger cellular progression.7,8

In the European Union, IBRANCE is an investigational agent and has not been approved.

IBRANCE is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HR+/HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.6 The indication in combination with letrozole is approved in the U.S. under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.6 Outside of the U.S., IBRANCE has received regulatory approval in 19 countries to date.

IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Neutropenia was the most frequently reported adverse reaction in Study 1 (PALOMA-1) (75%) and Study 2 (PALOMA-3) (83%). In Study 1, Grade 3 (57%) or 4 (5%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In Study 2, Grade 3 (56%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in about 1% of patients exposed to IBRANCE. One death due to neutropenic sepsis was observed in Study 2. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 14 of first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Pulmonary embolism (PE) has been reported at a higher rate in patients treated with IBRANCE plus letrozole in Study 1 (5%) and in patients treated with IBRANCE plus fulvestrant in Study 2 (1%) compared with no cases in patients treated either with letrozole alone or fulvestrant plus placebo. Monitor for signs and symptoms of PE and treat as medically appropriate.

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.

The most common adverse reactions (≥10%) of any grade reported in Study 1 of IBRANCE plus letrozole vs letrozole alone included neutropenia (75% vs 5%), leukopenia (43% vs 3%), fatigue (41% vs 23%), anemia (35% vs 7%), upper respiratory infection (31% vs 18%), nausea (25% vs 13%), stomatitis (25% vs 7%), alopecia (22% vs 3%), diarrhea (21% vs 10%), thrombocytopenia (17% vs 1%), decreased appetite (16% vs 7%), vomiting (15% vs 4%), asthenia (13% vs 4%), peripheral neuropathy (13% vs 5%), and epistaxis (11% vs 1%).

Grade 3/4 adverse reactions (≥10%) in Study 1 reported at a higher incidence in the IBRANCE plus letrozole group vs the letrozole alone group included neutropenia (54% vs 1%) and leukopenia (19% vs 0%). The most frequently reported serious adverse events in patients receiving IBRANCE plus letrozole were pulmonary embolism (4%) and diarrhea (2%).

Lab abnormalities occurring in Study 1 (all grades, IBRANCE plus letrozole vs letrozole alone) were decreased WBC (95% vs 26%), decreased neutrophils (94% vs 17%), decreased lymphocytes (81% vs 35%), decreased hemoglobin (83% vs 40%), and decreased platelets (61% vs 16%).

The most common adverse reactions (≥10%) of any grade reported in Study 2 of IBRANCE plus fulvestrant vs fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

Grade 3/4 adverse reactions (≥10%) in Study 2 reported at a higher incidence in the IBRANCE plus fulvestrant group vs the fulvestrant plus placebo group included neutropenia (66% vs 1%) and leukopenia (31% vs 2%). The most frequently reported serious adverse reactions in patients receiving IBRANCE plus fulvestrant were infections (3%), pyrexia (1%), neutropenia (1%), and pulmonary embolism (1%).

Lab abnormalities occurring in Study 2 (all grades, IBRANCE plus fulvestrant vs fulvestrant plus placebo) were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), and decreased platelets (62% vs 10%).

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg/day. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

IBRANCE has not been studied in patients with moderate to severe hepatic impairment or in patients with severe renal impairment (CrCl <30 mL/min).

On September 16, 2016 Eli Lilly and Company (NYSE: LLY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the granting of a conditional marketing authorization for olaratumab, in combination with doxorubicin, for the treatment of adults in the European Union (EU) with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin (Press release, Eli Lilly, SEP 16, 2016, View Source [SID:SID1234515180]). The CHMP reviewed olaratumab under EMA’s accelerated assessment program. If approved, olaratumab will be marketed under the trade name LARTRUVO.

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This is the first regulatory step in the world towards approval for olaratumab. The CHMP positive opinion is now referred for final action to the European Commission, which grants marketing authorization in the EU. The Commission usually makes a decision on marketing authorization within two to three months of the CHMP issuing its recommendation.

"Patients with advanced soft tissue sarcoma have been seeking new treatment options that can potentially extend lives, so they can have more time with their families and loved ones," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "Advanced soft tissue sarcoma is a rare disease that is difficult to treat, and this milestone brings us one step closer to providing physicians in Europe with a new option that they can offer to their patients."

This will be Lilly’s first conditional approval in the EU. As part of a conditional marketing authorization, Lilly will need to provide results from an ongoing Phase 3 study. This study, ANNOUNCE, is fully enrolled. Until availability of the full data, the CHMP will review the benefits and risks of olaratumab annually to determine whether the conditional marketing authorization can be maintained.

The EMA previously granted olaratumab with Orphan Drug Designation for the treatment of soft tissue sarcoma in the EU.

The EU submission is based on data from Phase 2 JGDG, an open-label, randomized trial that compared olaratumab, in combination with doxorubicin chemotherapy, to doxorubicin alone in patients with advanced STS not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin. Efficacy endpoints included progression-free survival, overall survival and objective response rate.

Lilly has also submitted the results of this study to the U.S. Food and Drug Administration (FDA) for regulatory review. The FDA recently granted Lilly Priority Review status for olaratumab. Lilly also has received additional designations for olaratumab from the FDA for this indication, including Breakthrough Therapy, Fast Track and Orphan Drug.

Notes to Editor
About Olaratumab
Olaratumab is a PDGFRα blocking antibody that specifically binds PDGFRα and prevents receptor activation. Olaratumab exhibited in vitro and in vivo anti-tumor activity against selected sarcoma cell lines and disrupted the PDGFRα signaling pathway in in vivo tumor implant models. Information about additional clinical trials for olaratumab in sarcoma can be found at ClinicalTrials.gov (in the search box on the home page, type in "olaratumab").

A Phase 3 trial of olaratumab and doxorubicin in advanced STS is fully enrolled (ClinicalTrials.gov Identifier: NCT02451943).

About the JGDG Trial
The open-label, randomized Phase 1b/2 study, JGDG, compared olaratumab in combination with doxorubicin chemotherapy to the control arm of doxorubicin alone in patients with unresectable, advanced STS not amenable to curative treatment with surgery or radiotherapy. After confirmation of safety in the Phase 1b portion of the study, 133 doxorubicin-naïve patients were randomized 1:1 in the Phase 2 portion of the study. A total of 66 patients were treated on the olaratumab-doxorubicin arm, and 67 on the placebo-doxorubicin arm. Efficacy endpoints included progression-free survival, overall survival and objective response rate.

About Sarcomas
Sarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage. STS is a complex disease with multiple subtypes, making it very hard to diagnose and difficult to treat. For decades, there have been no front-line therapeutic advancements for advanced STS that have improved overall survival. An estimated 23,000 people in the EU will be diagnosed with STS this year.