On June 3, 2019 Incyte (Nasdaq:INCY) reported primary efficacy results from the Novartis-sponsored GEOMETRY mono-1 Phase 2 clinical trial of capmatinib, an investigational, selective MET inhibitor (Press release, Incyte, JUN 3, 2019, View Source [SID1234536781]). The results demonstrate that capmatinib shows promise as a potential treatment option for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor a MET exon-14 skipping mutation. There are currently no approved targeted therapies to treat this particularly aggressive form of NSCLC.

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Results of the Phase 2 study will be presented at an oral session today, June 3, 2019, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting at 8:00 a.m. CDT (Abstract #9004)1.

GEOMETRY mono-1 is an international, prospective, multi-cohort, non-randomized, open-label study evaluating 97 adult patients with locally advanced or metastatic NSCLC harboring a MET exon-14 skipping mutation who received capmatinib tablets 400 mg orally twice daily. Primary efficacy results among treatment-naïve patients (Cohort 5b: 28 patients) included a 68 percent overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1 (95% [CI: [47.6-84.1]) and 41 percent of previously-treated NSCLC patients (Cohort 4: 69 patients) also responded (95% CI: [28.9 – 53.1]). Data on median duration of response (DOR), a key secondary endpoint, was 11.14 months (95% CI: [5.55-NE]) and 9.72 months (95% CI: [5.55-12.98]), in the treatment-naïve and previously-treated groups, respectively. Intracranial activity in 54 percent (n=7/13) of patients, including some cases of complete resolution of brain lesions, was also observed by ad hoc neuro-radiologist review in patients with brain lesions. All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response.

The most common treatment-related adverse events (AE) (≥10% all grades) across all cohorts (n=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%); the majority of the AEs were grades 1/2.

"In the absence of approved targeted therapies, patients with advanced or metastatic NSCLC harboring a MET exon-14 skipping mutation must rely on existing treatment approaches and, as a result, face a particularly poor prognosis," said Steven Stein, M.D., Chief Medical Officer, Incyte. "The results of the GEOMETRY mono-1 study to be presented at ASCO (Free ASCO Whitepaper) underscore the potential of capmatinib to meaningfully improve outcomes for this underserved subset of NSCLC patients."

The U.S. Food and Drug Administration (FDA) recently granted capmatinib Breakthrough Therapy designation for patients with metastatic NSCLC harboring a MET exon-14 skipping mutation with disease progression on or after platinum-based chemotherapy. Previously, both the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency recognized capmatinib with Orphan Drug status. It is estimated that 3 to 4 percent of all patients with NSCLC have an identified MET mutation2.

Novartis expects to submit a new drug application to the FDA for capmatinib as a treatment for patients with advanced NSCLC harboring a MET mutation in 2019.

About GEOMETRY mono-1

The Novartis-sponsored GEOMETRY mono-1 trial is an international, prospective, multi-cohort, non-randomized, open-label Phase 2 study to evaluate the efficacy and safety of single-agent capmatinib in adult patients with EGFR wildtype, ALK-negative rearrangement, advanced NSCLC harboring a MET amplification and/or mutation. Patients with locally advanced or metastatic NSCLC harboring a MET exon-14 skipping mutation (centrally confirmed) were assigned to Cohorts 4 (previously treated patients) or 5B (treatment-naïve), regardless of MET amplification/gene copy number and received 400 mg capmatinib tablets orally twice daily.

The primary endpoint was ORR based on BIRC assessment per RECIST v1.1. The key secondary endpoint was DOR by BIRC. The GEOMETRY mono-1 study found an ORR in the treatment-naïve patients (n=28) of 67.9 percent (95% CI: [47.6 – 84.1]) and an ORR of 40.6 % (95% CI: [28.9 – 53.1]) in the previously treated patients (n=69). Median DOR was 11.14 months (95% CI: [5.55-NE]) in treatment-naïve patients and 9.72 months (95% CI: [5.55-12.98]) in previously treated patients1.

The most common treatment-related AEs included peripheral edema, nausea, creatinine increase and vomiting. Of patients treated with capmatinib, 84 percent experienced an AE, with 36 percent having grade 3/4 AEs (only 4.5% were Grade 4)1.

About Capmatinib

Capmatinib is an investigational, oral and selective MET inhibitor discovered by Incyte that was licensed to Novartis in 2009. Under the terms of the Agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications. If capmatinib is successfully developed by Novartis, Incyte may become eligible for over $500 million in future milestones as well as royalties of between 12 and 14 percent on global sales by Novartis.

On June 3, 2019 AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) reported full results from the Phase III SOLO3 trial which compared Lynparza (olaparib) with physician’s choice of chemotherapy in the treatment of patients with germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer who had received two or more prior lines of chemotherapy (Press release, AstraZeneca, JUN 3, 2019, View Source [SID1234536798]).

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The results from the trial, presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) for Lynparza vs. chemotherapy (72.2% vs. 51.4% [95% CI, 1.40-4.58], p=0.002). ORR measures the proportion of patients with reduction in tumour burden of a predefined percentage.

The trial also met the key secondary endpoint of progression-free survival (PFS), demonstrating a statistically-significant and clinically-meaningful improvement in the time patients lived without disease progression for Lynparza (13.4 months) vs. chemotherapy (9.2 months [HR 0.62] p=0.013]).

José Baselga, Executive Vice President, Oncology R&D, said: "Lynparza provides a much-needed alternative and improvement over standard-of-care chemotherapy for patients with BRCA-mutated, advanced ovarian cancer. This is the fourth positive Phase II/III trial in advanced ovarian cancer for Lynparza, across multiple lines of therapy. We look forward to working closely with regulatory authorities to include findings from this trial in the prescribing information for Lynparza."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "Lynparza is the first and only PARP inhibitor to demonstrate efficacy versus chemotherapy in relapsed BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. The positive SOLO3 results reaffirm AstraZeneca and MSD’s ongoing commitment to explore potential treatment options beyond standard of care for BRCA-mutated with advanced stage disease."

Summary of resultsi

Lynparza
(300 mg bd)

Chemotherapy

ORR (primary endpoint)

Number of patients

151

72

Number of patients with response (%)

109 (72.2%)

37 (51.4%)

Odds ratio (95% CI)

2.53 (1.40, 4.58)

p-value

0.002

PFS (key secondary endpoint)i,ii

Number of patients

178

88

Number of patients with event (%)

110 (61.8%)

49 (55.7%)

Hazard ratio (95% CI)

0.62 (0.43, 0.91)

Median in months

13.4

9.2

p-value

0.013

iAssessed by blinded independent central review.

iiAnalysis was done at 59.8% maturity.

The safety and tolerability profile of Lynparza in the SOLO3 trial was consistent with previous trials. The most common adverse events (AEs) ≥ 20% were nausea (65%), fatigue/asthenia (52%), anaemia (51%), vomiting (38%), diarrhoea (28%), neutropenia (23%) and abdominal pain (21%). The most common ≥ Grade 3 AEs were anaemia (21%), neutropenia (10%), fatigue/asthenia (5%) and thrombocytopenia (4%). AEs led to dose interruption in 48% of patients on Lynparza while 7% of patients discontinued treatment.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is approved for multiple indications in advanced ovarian cancer and metastatic breast cancer and has been used in over 20,000 patients worldwide.

About SOLO3

SOLO3 was a Phase III randomised, open-label, controlled, multicentre trial to evaluate the efficacy and safety of Lynparza tablets following two or more prior lines of chemotherapy. The trial randomised 266 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation. Eligible patients were randomised (2:1) to receive Lynparza 300mg tablets twice daily or physician’s choice of single-agent chemotherapy (paclitaxel, topotecan, pegylated liposomal doxorubicin or gemcitabine). The primary endpoint was ORR by blinded independent central review and key secondary endpoints included PFS, time to second disease progression or death and overall survival. The SOLO3 trial addresses a post-approval commitment from the December 2014 accelerated US approval of Lynparza in ovarian cancer.

About ovarian cancer

Ovarian cancer is a leading cause of cancer death in women worldwide, with a five-year survival rate of 19%.1 In 2018, there were over 295,000 new cases diagnosed and around 185,000 deaths.2 Over 70% of women with ovarian cancer have advanced disease at the time of diagnosis, with up to 80% at risk of recurrence after initial treatment.3 Effective treatments are needed in later lines of therapy as patients typically obtain limited benefit after two prior lines of chemotherapy.3

About BRCA mutations

Breast cancer susceptibility genes 1/2 (BRCA1 and BRCA2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

About Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR.

Lynparza is currently approved in over 60 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved in the US, Canada and Brazil as 1st-line maintenance treatment of BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in nearly 40 countries, including the US and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy; in the EU this includes locally advanced breast cancer. Regulatory reviews are underway in other jurisdictions for both ovarian cancer and breast cancer.

Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

About the AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

On June 3, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp) Phase 2 clinical data in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) data are being presented today at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, being held from May 31-June 4, 2019, at McCormick Place in Chicago, Illinois (Press release, Stemline Therapeutics, JUN 3, 2019, View Source [SID1234536814]).

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ELZONRIS (tagraxofusp) is FDA-approved for the treatment of patients, adults and pediatric 2 years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN), and is commercially available in the U.S.

Details on the presentations are as follows:

Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)

Abstract: 7059
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenter: Mrinal M. Patnaik, MBBS; Mayo Clinic
Date: Monday, June 3
Time: 8:00 to 11:00 AM CT
Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis (MF)

Abstract: 7058
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenter: Naveen Pemmaraju, MD; The University of Texas MD Anderson Cancer Center
Date: Monday, June 3
Time: 8:00 to 11:00 AM CT
Please visit our Stemline corporate booth (#19156) during the 2019 ASCO (Free ASCO Whitepaper) annual meeting.

Stemline Provides Further Details on Next Steps for the ELZONRIS CMML Program
Given the encouraging clinical data generated from the ELZONRIS Phase 2 trial in patients with CMML, combined with feedback and guidance from the Food and Drug Administration (FDA), Stemline intends to open a Stage 3 cohort of the currently enrolling 0314 trial to serve as the pivotal program for ELZONRIS in patients with CMML. The planned primary endpoint is overall response rate (ORR); in addition, if certain other endpoints, including spleen size, are shown to have clinical benefit in the initial, Stage 3a, portion of the new cohort, then these endpoints could contribute to the primary evidence of efficacy in the final, Stage 3b, portion of the pivotal program. CD123 levels will also be evaluated in Stage 3a for potential enrichment in 3b.

Stage 3 will enroll patients with previously-treated CMML, and will be a single-arm, non-randomized trial designed to support potential registration. The protocol is currently being designed, and we expect to provide further details, including sample size, during 3Q19, with an expectation of opening the new cohort to enrollment later this year.

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented "With ELZONRIS now FDA-approved and commercially available for patients with BPDCN, our focus is on both ensuring patient access to ELZONRIS in the commercial setting as well as broadening the potential for ELZONRIS in additional indications. With this in mind, we are very excited to advance another ELZONRIS clinical program toward a potential second approval, this time in CMML, an aggressive and underserved malignancy."

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On June 3, 2019 Starpharma (ASX: SPL, OTCQX: SPHRY) reported a Development and Option Agreement with AstraZeneca (LON: AZN) to progress the development of a Dendrimer Enhanced Product (DEP) version of an undisclosed AstraZeneca major marketed oncology medicine (Press release, Starpharma, JUN 3, 2019, View Source [SID1234536835]). This is the second DEP commercial agreement Starpharma has signed with AstraZeneca, the first agreement being a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a Bcl2/xL inhibitor).

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The agreement was signed during the 2019 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) meeting in Chicago. ASCO (Free ASCO Whitepaper) attracts more than 40,000 cancer doctors, scientists, investors, pharmaceutical and life science executives.

Under this agreement, Starpharma will conduct preclinical testing of the DEP version of the AstraZeneca oncology product. At any time from the signing of this agreement and for a defined period after the completion of this testing, AstraZeneca may exercise its option and licence the DEP drug candidate for clinical and commercial development. If AstraZeneca exercises the option, an option exercise fee of US$5 million is payable to Starpharma, as well as industry standard development and commercialisation milestones and escalating royalties on sales. Further details regarding the major oncology medicine involved, drug candidates, and terms of the agreement remain confidential at this time for competitive reasons.

In the event AstraZeneca does not exercise its option to licence the DEP drug candidate within the defined period, Starpharma has the option to license the rights to develop and commercialise this DEP drug either itself or through a sub-licensee with milestones and royalties paid to AstraZeneca upon commercialisation of the resultant DEP product.

Dr Jackie Fairley, Starpharma Chief Executive Officer, said: "We are delighted to sign a new commercial DEP agreement at ASCO (Free ASCO Whitepaper) with our long-standing partner, AstraZeneca. This agreement follows a successful research program under which we identified a promising DEP candidate with a number of potential benefits. This agreement represents the culmination of that work and this DEP product has the potential to provide significantly enhanced patient benefit. Unlike our first DEP agreement with AstraZeneca, which applies DEP to novel oncology drug candidates, this agreement is for an existing major AstraZeneca oncology medicine and provides further validation of the value of the DEP platform and its broad application to both new chemical entities and existing products."

Susan Galbraith, Senior Vice President, R&D Early Oncology, AstraZeneca, said: "Building on our long-standing and successful working relationship with Starpharma, this agreement will enable us to further evaluate the potential of the DEP technology with the aim of improving treatment outcomes for patients."

Starpharma’s DEP platform remains available for further partnerships. Licences are typically product specific and structured to allow for multiple partnered-DEP programs to run in parallel.

On June 3, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the final progression-free survival (PFS) data and the second interim analysis of overall survival (OS) from the Japanese phase III J-ALEX study for Alecensa were presented on June 2 (local time) at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 31 to June 4 in Chicago, IL, United States (Press release, Chugai, JUN 3, 2019, View Source [SID1234536782]). J-ALEX study compared Alecensa and crizotinib as the first-line treatment for patients with ALK fusion gene positive non-small cell lung cancer (NSCLC).

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Abstract #9092;
Final PFS analysis and safety data from the phase III J-ALEX study of Alectinib (ALC) vs. Crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive Non-Small Cell Lung Cancer (ALK+NSCLC)

"The long-term data from the J-ALEX study confirms the benefits of Alecensa as the first-line treatment for patients with ALK-positive NSCLC," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit.

The J-ALEX study is an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was PFS as assessed by an independent review facility (IRF). The secondary endpoints included OS, time to disease progression of brain metastases in patients with brain metastases at baseline, and safety.

In February, 2016, Chugai carried out a prospectively defined interim analysis, and had an independent data monitoring committee examine the results. Since the results showed that Alecensa significantly prolonged PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the study [Alecensa arm: not estimable (95% CI: 20.3-not estimable), crizotinib arm: 10.2 months (95% CI: 8.2-12.0), HR=0.34 (99.7% CI: 0.17-0.70), stratified log-rank test, p<0.0001)].

Latest data from the J-ALEX study shows:

Risk of progression or death was reduced by 63% (HR=0.37, 95% CI: 0.26-0.52) in the Alecensa arm compared to the crizotinib arm. Median PFS (primary endpoint) was 34.1 months in the Alecensa arm (95% CI: 22.1-not estimable) versus 10.2 months (95% CI: 8.3-12.0) in the crizotinib arm.
In the second interim analysis, the superiority of OS in the Alecensa arm over the crizotinib arm was not conclusive (stratified HR=0.80, 95% CI: 0.35-1.82). The investigation on OS will be continued.
The safety profile of Alecensa was consistent with previous reports.
[Reference information]
Media release issued by Chugai on May 11, 2017:
Results of the J-ALEX Study for Chugai’s Alecensa are Published in "The Lancet" Online;
View Source