A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from AstraZeneca, Merck & Co.,Amgen, and Boehringer Ingelheim.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, July 26, 2017 to Tuesday, August 1, 2017.

AstraZeneca Gets FDA Grants Breakthrough Therapy Designation for Lung Cancer Drug…
The US Food and Drug Administration (FDA) has granted AstraZeneca and MedImmune, its global biologics research and development arm, breakthrough therapy designation for Imfinzi (durvalumab) for treating patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

Imfinzi, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, which counters the tumor’s immune-evading tactics and induces an immune response, according to AstraZeneca.

The breakthrough therapy designation for Imfinzi follows the recent accelerated approval from the FDA for Imfinzi in previously treated patients with advanced bladder cancer. It is the fourth breakthrough therapy designation AstraZeneca has received from the FDA for a new oncology cancer medicine over the past three years and the second for Imfinzi, according to information from AstraZenca.

Imfinzi is being studied in multiple monotherapy trials and combination trials with tremelimumab, another AstraZeneca immuno-oncology drug and other immuno-oncology drug candidates. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma and hematological malignancies.

Source: AstraZeneca

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…But Has Setback for Lung Cancer Drug Indication
AstraZeneca and MedImmune, its global biologics research and development arm, report Phase III trials results evaluating progression-free survival (PFS) from the combination of its cancer drug, Imfinzi (durvalumab), and its immuno-oncology drug candidate, tremelimumab, did not meet the primary endpoint of improving PFS compared to platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic first-line non-small cell lung cancer. As a secondary endpoint, although not formally tested, Imfinzi monotherapy would not have met a pre-specified threshold of PFS benefit over SoC in this disease setting.

The trial will continue to assess two additional primary endpoints of overall survival (OS) for Imfinzi as a monotherapy and for OS for the Imfinzi plus tremelimumab combination. Final OS data from both primary endpoints are expected during the first half of 2018.

AstraZeneca recently received accelerated approval from the US Food and Drug Administration for Imfinzi in previously treated patients with locally advanced or metastatic urothelial carcinoma.

Source: AstraZeneca

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Merck & Co. Has Setback for Additional Cancer Indication
Merck & Co. reports that a Phase III trial investigating its cancer drug, Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) did not meet its pre-specified primary endpoint of overall survival. The safety profile observed was consistent with that observed in previously reported studies of Keytruda; no new safety signals were identified.

In August 2016, the US Food and Drug Administration (FDA) approved Keytruda for treating patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. The current indication remains unchanged, and clinical trials continue, including aPhase III clinical trial of Keytruda in the first-line treatment of recurrent or metastatic HNSCC.

Keytruda is Merck & Co.’s blockbuster immuno-oncology therapy with 2016 global sales of $1.4 billion. It is indicated for treating multiple cancers. In the US, the drug is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma, a common form of bladder cancer, who are ineligible for cisplatin-containing chemotherapy. Keytruda is also approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Keytruda is also approved in the US for treating unresectable or metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and refractory classical Hodgkin lymphoma.

Source: Merck & Co.

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FDA Accepts BMS’ sBLA for New Dosing of Immuno-Oncology Therapy
The US Food and Drug Administration (FDA) has accepted Bristol-Myers Squibb’s (BMS) supplemental biologics license applications (sBLAs) to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. Opdivo is a blockbuster anti-cancer drug for BMS with 2016 sales of $3.77 billion.

The applications are under review with an action date of March 5, 2018.

In the US, Opdivo is indicated for treating BRAF V600 mutation-positive unresectable or metastatic melanoma and BRAF V600 wild-type unresectable or metastatic melanoma as a single agent; unresectable or metastatic melanoma in combination with Yervoy (ipilimumab); metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; and locally advanced or metastatic urothelial carcinoma.

Source: Bristol-Myers Squibb

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Eisai Submits Fillings to FDA, EMA for Additional Use for Cancer Drug…
Eisai has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency for its in-house discovered and developed anticancer agent, lenvatinib mesylate, for treating hepatocellular carcinoma (HCC), a primary malignancy of the liver that occurs predominantly in patients with underlying chronic liver disease and cirrhosis. Lenvatinib for treating HCC is designated as an orphan drug by the FDA.

Lenvatinib is approved as a treatment for refractory thyroid cancer in over 50 countries, including the US, Japan, and in Europe, under the brand name Lenvima. Additionally, lenvatinib in combination with everolimus is approved for treating renal cell carcinoma (RCC) over 35 countries, including the US and in Europe. In Europe, lenvatinib was launched under the brand name Kisplyx for RCC.

Source: Eisai

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…And Gets FDA OK Additional Use for Antiepileptic Drug

Eisai Inc., Eisai’s US subsidiary, has received approval from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Eisai’s antiepileptic drug (AED), Fycompa (perampanel), as a monotherapy use for treating partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older.

The FDA’s regulatory pathway for monotherapy use, which was communicated in September 2016, states that “it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial-onset seizures to their use as monotherapy for the treatment of partial-onset seizures.”

Fycompa is a AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors, according to Eisai.

It was originally approved in the US as an adjunctive therapy for treating partial-onset seizures (with or without secondarily generalized seizures) and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

Source: Eisai

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BI Begins Clinical Development of Biosimilar to Abbvie’s Humira
Boehringer Ingelheim (BI) reports that the first patient has been enrolled into its interchangeability study to demonstrate that BI 695501, a biosimilar candidate to AbbVie’s Humira (adalimumab), is interchangeable with the US-marketed formulation of Humira (40mg/0.8mL). Humira is AbbVie’s top-selling drug with 2016 global sales of $16 billion.

The study will compare the pharmacokinetics and clinical outcomes between patients receiving Humira continuously, versus those who switch repeatedly between Humira and BI 695501, Boehringer Ingelheim’s adalimumab biosimilar candidate. The study will also assess safety, immunogenicity and efficacy.

BI 695501 has been accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration. Phase III results demonstrating clinical equivalence of BI 695501 to Humira in people living with rheumatoid arthritis were recently presented at the annual European Congress of Rheumatology.

Source: Boehringer Ingelheim

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Amgen Gets Priority Review for New Cardio Use for Anti-cholesterol Drug… 
The US Food and Drug Administration (FDA) has granted priority review for Amgen’s supplemental biologics license application (sBLA) for its anti-cholesterol drug, Repatha (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the US prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study.

The FDA has set a Prescription Drug User Fee Act action date of December 2, 2017.

A second application seeking to expand the lipid-lowering indication to include additional patient populations studied was also accepted by the FDA.

Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for treating adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol.

Repatha is approved in more than 50 countries, including the US, Japan, Canada, and in all 28 countries that are members of the European Union. Applications in other countries are pending.

Source: Amgen

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.. Submits sBLA For Osteoporosis Drug
Amgen has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis.

Prolia is indicated for treating postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures.

The drug is also indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. The same treatment is indicated for women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Source: Amgen