AstraZeneca (AZN) Announces Significant PFS Data from LYNPARZA Phase III SOLO-2

October 26, 2016 7:01 AM EDT

Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.

AstraZeneca (NYSE: AZN) announced positive results from the Phase III SOLO-2 trial designed to determine the efficacy of LYNPARZA (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer.1 Results from the trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free survival (PFS) among patients treated with LYNPARZA compared to placebo and provide additional evidence to support the potential use of LYNPARZA in this patient population.

Importantly, the median PFS in the LYNPARZA arm of SOLO-2 substantially exceeded that observed in the Phase II maintenance study in patients with platinum-sensitive relapsed ovarian cancer (Study 19).2

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “We are pleased with the robust improvement in progression-free survival demonstrated by LYNPARZA in the SOLO-2 trial. We will work with regulatory authorities to make LYNPARZA tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of LYNPARZA, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.”

Initial findings demonstrate that safety profile with LYNPARZA tablets was consistent with previous studies.2 Full results of SOLO-2 will be presented at a forthcoming medical meeting.

Today’s positive results follow the Fast Track Designation for LYNPARZA by the US FDA earlier this year, in patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer.3

LYNPARZA is the first PARP inhibitor approved in the US. LYNPARZA capsules (400mg twice daily) are FDA-approved as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. LYNPARZA is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.4 LYNPARZA tablets are an investigational formulation and are not FDA-approved for any use.1

Important Safety Information About LYNPARZA™ (olaparib)

There are no contraindications for LYNPARZA.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1% of patients treated with LYNPARZA, and the majority of those reports were fatal. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. In a randomized placebo-controlled trial, MDS/AML occurred in 2% of patients treated with LYNPARZA. All of these patients had previous chemotherapy with platinum agents and/or other DNA damaging agents, including radiotherapy, and some of these patients also had a history of previous cancer or of bone marrow dysplasia.

Monitor patients for hematological toxicity at baseline and monthly thereafter. Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤CTCAE Grade 1). For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood counts weekly until recovery. If the levels have not recovered to CTCAE Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, fever, cough, wheezing, or a radiological abnormality occurs, interrupt treatment with LYNPARZA and initiate prompt investigation. Discontinue if pneumonitis is confirmed.

Embryo-Fetal Toxicity: LYNPARZA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy by using effective contraception during treatment and for at least one month after receiving the last dose of LYNPARZA.

ADVERSE REACTIONS

In clinical studies, the most common adverse reactions (Grades 1-4) in ≥20% of patients included anemia (34%), nausea (75%), fatigue (including asthenia) (68%), vomiting (43%), diarrhea (31%), dysgeusia (21%), dyspepsia (25%), headache (25%), decreased appetite (25%), nasopharyngitis/pharyngitis/URI (43%), cough (21%), arthralgia/musculoskeletal pain (32%), myalgia (25%), back pain (25%), dermatitis/rash (25%), and abdominal pain/discomfort (47%).

Common lab abnormalities (Grades 1-4) included anemia (90%), neutropenia (32%), thrombocytopenia (30%), lymphopenia (56%), mean corpuscular volume elevation (85%), and increase in creatinine (30%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA in combination with other myelosuppressive anticancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid concomitant use of strong and moderate CYP3A inhibitors. If the strong or moderate CYP3A inhibitor must be co-administered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit and Seville oranges during LYNPARZA treatment.

CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers when using LYNPARZA. If a moderate inducer cannot be avoided, be aware of a potential for decreased efficacy of LYNPARZA.

USE IN SPECIFIC POPULATIONS

Nursing Mothers: Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from LYNPARZA, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Renal Impairment: No dosage adjustment is necessary for patients with mild renal impairment (CLcr 51-80 mL/min). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose to 300 mg twice daily. There are no data in patients with severe renal impairment (CLcr <50 mL/min) or end-stage renal disease (CLcr ≤30 mL/min).

Hepatic Impairment: There are no data in patients with baseline hepatic impairment (serum bilirubin >1.5 times upper limit of normal).

Please see complete Prescribing Information, including Patient Information (Medication Guide).



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In






Related Categories

Corporate News, FDA, Hot Corp. News, Management Comments

Related Entities

Twitter

Add Your Comment