This week, the FDA granted approvals to Merck’s MRK Gardasil Vaccine and Keytruda, Novartis’ NVS Cosentyx and Glaxo’s GSK Tivicay for expanded indications/patient populations and Lilly’s LLY ultra-rapid-acting lispro, Lyumjev. Lilly began its own phase III study on its JAK inhibitor, Olumiant in COVID-19 patients. Lilly, AbbVie ABBV, Roche RHHBY and Sanofi announced successful late-stage study results.
Recap of the Week’s Most Important Stories:
Lilly Begins Phase III Study on Olumiant in COVID-19 Patients: Lilly announced that the first patient has been dosed in the phase III study evaluating Olumiant (baricitinib) as a potential treatment for hospitalized patients diagnosed with COVID-19. The study to be conducted in the United States., Europe and Latin America will enroll 400 patients with data expected to be released in a few months. The study will complement an already ongoing study of Olumaint with Gilead’s remdesivir being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) for hospitalized patients with COVID-19 infections. The NIAID study dosed the first patient last month.
Lilly’s Verzenio significantly reduced the risk of cancer returning in a large phase III study in patients with high risk HR+, HER2- early breast cancer. Interim data from the phase III monarchE study showed that Verzenio in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence or death compared to standard adjuvant ET alone, thereby meeting the study’s primary endpoint of invasive disease-free survival (IDFS). Approximately 30% of people diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning and Verzenio is the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence in such patients. Lilly will submit data from the study to regulatory authorities by this year end.
Meanwhile, the FDA granted approval to Lyumjev, Lilly’s ultra-rapid-acting lispro, a new fast-acting formulation of Lilly’s insulin lispro (Humalog) to improve glycemic control in adults with type I and type II diabetes. Lyumjev was approved in the European Union in March this year.
FDA Grants Expanded Approvals to Merck’s Gardasil Vaccine and Keytruda: The FDA approved an expanded indication for Merck’s Gardasil 9 vaccine. The latest accelerated approval is for preventing certain HPV-related oropharyngeal and head and neck cancers. The vaccine was until now approved for the prevention of HPV-related cervical, vulvar, vaginal, and anal cancers.
The FDA also granted accelerated approval to Keytruda, as a monotherapy in adult and pediatric patients whose unresectable or metastatic solid tumors are tumor mutational burden-high (TMB-H) and who have progressed following prior treatment. The approval was partly based on data from the phase II KEYNOTE-158 study. This is the second time Merck has gained an expanded approval for Keytruda based on a biomarker, regardless of cancer tumor type. In 2017, the FDA had approved Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.
FDA Approves Glaxo’s Tivicay for Pediatric Use: The FDA also approved Glaxo’s Tivicay PD, the first ever dispersible tablet formulation of dolutegravir for treating HIV-1 in pediatric patients. The tablet will be available for oral suspension to treat pediatric patients aged at least four weeks and weighing at least 3kg. Meanwhile, the FDA also approved an expanded label of its marketed drug, Tivicay 50 mg film-coated tablet for use in pediatric HIV patients weighing 20kg and above. Until now, Tivicay was approved for use in children from six years of age and weighing more than 30kg
FDA Approves Novartis’ Cosentyx for 4th indication: The FDA also approved Novartis’ Cosentyx for its fourth indication —active non-radiographic axial spondyloarthritis (nr-axSpA). The approval was based on data from the phase III PREVENT study. Cosentyx was approved for nr-axSpA in Europe in April this year. The other three indications for which Cosentyx is presently approved are psoriatic arthritis, moderate-to-severe plaque psoriasis and ankylosing spondylitis.
AstraZeneca Inks Europe Supply Deal for Coronavirus Vaccine: AstraZeneca AZN signed an agreement with Europe’s Inclusive Vaccines Alliance (IVA), a group formed by Germany, France, Italy and the Netherlands to supply 400 million doses of its potential coronavirus vaccine, which it is developing with Oxford University, to these countries. AstraZeneca has an agreement with Oxford University for the global development and distribution of the latter’s potential recombinant adenovirus vaccine, now known as AZD1222, to prevent COVID-19. AZD1222 is currently being evaluated in a phase II/III study, which began last month. AstraZeneca has signed a number of supply deals across the world to support access to the vaccine. These supply deals will require it to produce 2 billion doses of the vaccine, if it is successfully developed.
Roche’s Prostate Cancer Candidate Meets One Goal in Phase III Study: Roche’s IPATential150 phase III study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints of radiographic progression free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumors had PTEN loss. In the study, treatment with ipatasertib combo led to a statistically significant reduction in the risk of disease worsening or death in the above-mentioned patient group, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. The other co-primary endpoint was rPFS in the overall study population, which was not met.
Meanwhile, Roche’s late-stage study evaluating Tecentriq in combination with chemotherapy in previously untreated, early triple-negative breast cancer (TNBC) patients met its primary endpoint. The study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of these patients, regardless of PD-L1 expression.
AbbVie’s Rinvoq Meets Goals in Atopic Dermatitis Study: AbbVie’s newly launched rheumatoid arthritis drug Rinvoq (upadacitinib) showed significant improvement in skin clearance and itch in a phase III study evaluating it for moderate-to-severe atopic dermatitis in adults and adolescents. The top-line data showed that both doses of upadacitinib (15 mg and 30 mg) monotherapy met all primary and secondary endpoints versus placebo. The two primary endpoints were at least a 75% improvement in the Eczema Area Severity Index (EASI 75) and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of clear or almost clear (0/1) skin at week 16.
Sanofi’s Pompe Disease Candidate Meets Primary Goal in Study: Sanofi announced data from a phase III study evaluating its investigational enzyme replacement therapy (ERT), avalglucosidase alfa, for the treatment of late-onset Pompe disease. Avalglucosidase alfa met the primary endpoint of the study by demonstrating non-inferiority in improving respiratory function compared to alglucosidase alfa (standard of care) in Pompe disease. The candidate led to a 2.4-point improvement in percent-predicted forced vital capacity, an important measure of respiratory function in Pompe disease, compared to alglucosidase alfa. Meanwhile, the patients treated with avalglucosidase alfa walked 30 meters farther than those treated with standard of care, as measured by the 6-minute walk test, a key secondary endpoint of the study.
Sanofi said it will invest €610 million to establish a state-of-the-art vaccine production site and a new research center in France.
The NYSE ARCA Pharmaceutical Index rose 2.85% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the nine major stocks performed in the last five trading sessions.
Last week, while Lilly recorded the highest increase (11.8%), Merck declined the most (1.5%).
In the past six months, Lilly has risen the most (21.6%) while Merck declined the most (16.8%).
(See the last pharma stock roundup here: Coronavirus Updates From ABBV, LLY, JNJ, FDA Approvals)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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