This week, the FDA granted approval to Glaxo’s (GSK - Free Report) asthma drug, Nucala for pediatric use. Meanwhile, Pfizer (PFE - Free Report) , Allergan (AGN - Free Report) and Roche (RHHBY - Free Report) provided regular pipeline/regulatory updates J&J (JNJ - Free Report) , AstraZeneca (AZN - Free Report) and Eli Lilly (LLY - Free Report) presented data from studies at medical conferences held this week.
Recap of the Week’s Most Important Stories
FDA Nod to Glaxo’s Asthma Drug for Children: The FDA granted approval to Glaxo’s severe eosinophilic asthma drug Nucala for use in pediatric patients (aged six to 11 years) in the United States. The drug is already marketed in the United States and EU for severe eosinophilic asthma patients aged 12 years or older. In the EU, it received approval for pediatric use (from aged six-17 years) in August last year.
Lilly’s RET Inhibitor Shrinks Tumors in NSCLC Study: At the World Conference on Lung Cancer (WCLC) 2019 held in Spain, Lilly presented data from a phase I/II registrational study on its oral RET inhibitor, selpercatinib (LOXO-292), which was added to its pipeline following the February acquisition of Loxo Oncology. As of the cut-off date of Jun 17, 2019, the candidate demonstrated a 68% objective response rate (ORR) or shrinkage in tumor size in heavily pretreated patients with RET fusion-positive non-small cell lung cancer (NSCLC). Meanwhile, the median duration of response was 20.3 months and median progression-free survival (PFS) was 18.4 months in the selpercatinib arm as of the same date. Lilly plans to file a regulatory application for selpercatinib later this year.
FDA and EMA Accept Allergan’s Filings for Abicipar Pegol: Allergan and its partner Molecular Partners announced that the filings for its long-acting anti-VEGF product, abicipar pegol has been accepted for review by regulatory authorities in the United States and Europe. Abicipar pegol has been developed for the treatment of age-related neovascular macular degeneration (nAMD). While the FDA is expected to give its decision in mid-2020, European Medicines Agency (EMA) is expected to decide on the same in the second half of 2020. The biologics license application (BLA) and marketing authorization application (MAA) filings were based on data from two phase III studies — SEQUOIA and CEDAR.
Pfizer’s Positive Preliminary Data on Pneumococcal Vaccine Candidate: Pfizer announced positive preliminary results from initial three doses of a phase II study on its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077. The study evaluated the candidate for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes in healthy infants. Data showed that PF-06482077 has an overall similar safety profile to Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 in this patient population. The vaccine candidate also induced immune responses for all 20 serotypes in infants. PF-06482077 includes all the 13 serotypes contained in Prevnar 13 along with seven additional serotypes
Meanwhile, the company also said it has completed enrolment of its three phase III studies evaluating PF-06482077 for the prevention of invasive disease and pneumonia in adults. Pfizer plans to file a BLA for the PF-06482077 by the end of 2020.
Roche’s Tecentriq Shows OS Benefit in Some Lung Cancer Patients: Roche announced positive data from the phase III IMpower110 study, which evaluated its PD-L1 inhibitor, Tecentriq as a first-line monotherapy treatment in advanced non-squamous and squamous NSCLC patients without ALK or EGFR mutations. The data demonstrated that Tecentriq, as a first-line monotherapy, helped these patients live longer compared with chemotherapy. Tecentriq monotherapy showed significant overall survival (OS) benefit over chemotherapy in patients with high PD-L1 expression, thereby meeting the study’s primary endpoint.
Roche’s phase III FeDeriCa study, evaluating its fixed-dose subcutaneous combination of Perjeta and Herceptin in patients with HER2-positive breast cancer, met its primary endpoint. The single injection, which has been developed to reduce the time spent receiving treatment as it is administered under the skin quickly, showed non-inferiority when compared to intravenous formulations.
Roche also presented full pivotal data from a phase III study on satralizumab evaluating it for the treatment of neuromyelitis optica spectrum disorder at the annual conference of The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Stockholm, Sweden. The data showed that satralizumab monotherapy reduced the risk of relapses by 55% compared to placebo in the overall population.
J&J Presents New Data on Ponesimod and Spravato: J&J presented new data from a phase III head-to-head study (OPTIMUM) evaluating ponesimod versus Sanofi’s Aubagio in adults with relapsing multiple sclerosis at ECTRIMS. The data demonstrated superior efficacy of ponesimod versus Aubagio on the primary endpoint and most secondary endpoints. In July, the company had announced that the OPTIMUM study met its primary and most secondary endpoints. Along with the latest release, the company said that treatment with ponesimod led to a statistically significant reduction of annualized relapse rate (ARR), which was the study’s primary endpoint, compared to Aubagio.
J&J’s two phase III studies evaluating its newly approved anti-depressant, Spravato (esketamine) nasal spray in severely ill patient population, met their respective primary efficacy endpoint. The primary endpoint of the studies was a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Data showed that treatment with Spravato plus comprehensive standard of care (SOC) treatment led to rapid reduction of depressive symptoms in adult patients with major depressive disorder who have active suicidal ideation with intent. The data was presented at the European College of Neuropsychopharmacology (ECNP) meeting held in Copenhagen, Denmark.
Detailed Data from AstraZeneca’s CASPIAN Study: At the WCLC, AstraZeneca presented detailed data from the phase III CASPIAN study on Imfinzi in first-line extensive-stage small cell lung cancer — the most aggressive type of lung cancer. Interim data from the study was presented in June when the company said that that treatment with Imfinzi plus platinum-based chemotherapy led to a statistically-significant and clinically-meaningful improvement in OS versus chemotherapy alone. Along with the latest release, AstraZeneca said that the median OS was 13.0 months in the Imfinzi plus chemotherapy arm versus 10.3 months for standard of care medicines. The PFS rate at 12 months was higher at 17.5% in the Imfinzi plus chemotherapy arm versus 4.7% in the SOC arm. The confirmed ORR was 67.9% in the Imfinzi plus chemotherapy arm versus 57.6% in the SOC arm.
The NYSE ARCA Pharmaceutical Index declined 0.3% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
Last week, while Pfizer rose the most (2.6%), AstraZeneca declined the most (4.1%).
In the past six months, Merck has been the biggest gainer (2.2%) while Lilly lost the most (9.5%).
(See the last pharma stock roundup here: AGN’s Opioid Settlement, Line Extension Nod in EU for MRK, JNJ Drugs)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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