<
News + Analysen
News + Adhoc
Analysen
Kursziele
>
<
Unternehmen
Termine
Profil
>
<
zugeh. Wertpapiere
Strukturierte Produkte
>
29.05.2020 14:00:00

Press Release: Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar(R) + Mekinist(R) ...

-- More than half of patients with BRAF-mutated advanced melanoma taking

Tafinlar + Mekinist were alive and free of a relapse at 5-years1

-- Study conclusions are drawn from the largest dataset and longest

follow-up to date of patients with BRAF-mutated melanoma treated with

(Anzeige)Passende neue Barrier Reverse Convertibles

targeted therapy following the surgical removal of their cancer1,2

-- Data are from the five-year follow-up of the COMBI-AD trial presented at

the ASCO20 Virtual Scientific Program1

Basel, May 29, 2020 -- Novartis announced today updated results from the

landmark COMBI-AD clinical trial, demonstrating that treatment with

Tafinlar(R) (dabrafenib) and Mekinist(R) (trametinib) following the

surgical removal of melanoma offers a long-term and durable relapse-free

survival (RFS) benefit to high-risk patients diagnosed with stage III,

BRAF-mutation positive melanoma(1). Researchers reported that 52% (95%

CI, 48%-58%) of patients treated with adjuvant Tafinlar + Mekinist were

alive and relapse-free at five years(1). Among patients in the study's

placebo arm 36% (95% CI, 32%-41%) were alive and relapse-free at the

time of this analysis, generally consistent with typical melanoma

relapse-free survival rates seen among patients with resected stage III

disease without treatment(1,3-5). Consistent RFS benefit was observed

across all AJCC 7 stage III subgroups(1,6).

Median RFS, or the length of time when 50% of patients are still alive

and relapse-free, was not yet reached at the 5-year data cut-off for

patients on Tafinlar + Mekinist treatment, suggesting long-term benefit

of targeted therapy in the adjuvant (post-surgical) setting (NR; 95% CI,

47.9 mo-NR)(1). Median RFS was 16.6 months for patients taking a

placebo (95% CI, 12.7-22.1 mo)(1). Treatment with Tafinlar + Mekinist

reduced the risk of relapse or death by 49% compared to placebo (hazard

ratio [HR] 0.51; 95% CI 0.42, 0.61)(1).

"Our goal as clinicians is to give our stage III patients the best

chance for relapse-free survival," said Prof. Axel Hauschild, MD,

Professor of Dermatology, University Hospital Schleswig-Holstein,

Germany. "Results from COMBI-AD show that adjuvant treatment with

Tafinlar + Mekinist after surgical resection gives melanoma patients the

chance for long-term relapse-free survival. Five years is a clinically

and emotionally significant milestone for patients. Recurrent BRAF+

melanoma, once spread to other organs, can be more dangerous and

difficult to treat. The durable, long-term results seen among patients

in the COMBI-AD trial clearly point to the important role targeted

therapy plays in the adjuvant setting."

The COMBI-AD study results are drawn from a prospective analysis of 870

patients with BRAF V600-mutated melanoma treated with Tafinlar +

Mekinist after their surgery(1). This study represents the largest

collection of data and longest follow-up to date in this patient

population treated with targeted therapy(2). The findings were

presented at the ASCO20 Virtual Scientific Program (Abstract #10001)(1)

.

"The five-year survival mark is an important and predictive milestone

for people with melanoma and the doctors who care for them," said John

Tsai, MD, Head of Global Drug Development and Chief Medical Officer,

Novartis. "We see an almost 50% risk reduction in melanoma relapse or

death in the COMBI-AD data announced today, and we believe patients will

find this information helpful in choosing a treatment after surgery. We

thank the patients and their families who participated in this long-term

clinical trial. Their participation and commitment is helping the

community learn how a BRAF-targeted therapy can reimagine outcomes for

patients with resectable stage III melanoma."

Visit https://www.virtualcongress.novartis.com/ASCO20 for the latest

information from Novartis, including our commitment to the Oncology

community, and access to our ASCO20 Virtual Scientific Program data

presentations (for registered participants).

About the COMBI-AD Study(1,2,6,7)

COMBI-AD is a pivotaI Phase III study evaluating Tafinlar (dabrafenib) +

Mekinist (trametinib) among patients with stage III, BRAF V600E/K-mutant

melanoma without prior anticancer therapy. It is the longest follow-up,

at 60 months, and largest dataset to date of patients with Stage III

melanoma receiving targeted therapy for adjuvant treatment.

It is a two-arm, randomized, double-blind Phase III study of dabrafenib

in combination with trametinib versus two placebos in the adjuvant

treatment of melanoma after surgical resection. Patients with completely

resected, histologically confirmed, BRAF V600E/K mutation-positive,

high-risk [stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc]

cutaneous melanoma were screened for eligibility. Subjects were

randomized to receive either dabrafenib (150 mg twice daily) and

trametinib (2 mg once daily) combination therapy or two placebos for up

to one year. The primary end point is recurrence-free survival, and

secondary endpoints include overall survival, distant metastasis-free

survival, freedom from relapse analysis and safety.

Melanoma staging assessed based on AJCC guidelines version 7.

During the five-year follow-up, updated safety analyses were not

performed because no patients remained on therapy during the extended

follow--up period.

About Melanoma

There are more than 285,000 new diagnoses of melanoma (Stages 0-IV)

worldwide each year, approximately half of which have a BRAF

mutation(8,9). Genetic tests can determine whether a tumor has a BRAF

mutation(10).

One way melanoma is staged is by how far it has metastasized(11). In

stage III melanoma, tumors have spread to the regional lymph nodes,

presenting a higher risk of recurrence or metastases(11). Patients who

receive surgical treatment for stage III melanoma may have a high risk

of recurrence because melanoma cells may remain in the body after

surgery(12). Generally the majority of relapses in stage III melanoma

occur within 5 years(13). Patients should ask their doctor if they are

at risk for melanoma returning(12).

About Tafinlar + Mekinist Combination

TAFINLAR and MEKINIST are prescription medicines that can be used in

combination to treat people with a type of skin cancer called melanoma:

-- That has spread to other parts of the body (metastatic) or cannot be

removed by surgery (unresectable), and

-- That has a certain type of abnormal "BRAF" (V600E or V600K

mutation-positive) gene

TAFINLAR and MEKINIST are prescription medicines that can be used in

combination to help prevent melanoma that has a certain type of abnormal

"BRAF" gene from coming back after the cancer has been removed by

surgery.

TAFINLAR and MEKINIST are prescription medications that can be used in

combination to treat a type of lung cancer called non-small cell lung

cancer (NSCLC) that has spread to other parts of the body (metastatic

NSCLC), and that has a certain type of abnormal "BRAF V600E" gene.

TAFINLAR and MEKINIST are prescription medications that can be used in

combination to treat a type of thyroid cancer called anaplastic thyroid

cancer (ATC):

-- that has spread to other parts of the body and you have no satisfactory

treatment options and

-- that has a certain type of abnormal "BRAF" gene

TAFINLAR, in combination with MEKINIST, should not be used to treat

people with wild-type BRAF melanoma. MEKINIST should not be used to

treat people who already have received a BRAF inhibitor for treatment of

their melanoma and it did not work or is no longer working.

Your health care provider will perform a test to make sure that TAFINLAR

and MEKINIST, in combination, are right for you.

It is not known if TAFINLAR and MEKINIST are safe and effective in

children.

TAFINLAR and MEKINIST, in combination, may cause serious side effects

such as the risk of new cancers, including both skin cancer and nonskin

cancer. Patients should be advised to contact their health care provider

immediately for any skin changes, including a new wart, skin sore, or

bump that bleeds or does not heal, or a change in the size or color of a

mole.

When TAFINLAR is used in combination with MEKINIST, it can cause serious

bleeding problems, especially in the brain or stomach, that can lead to

death. Patients should be advised to call their health care provider and

get medical help right away if they have any signs of bleeding,

including headaches, dizziness, or feel weak, cough up blood or blood

clots, vomit blood or their vomit looks like "coffee grounds," or red or

black stools that look like tar.

MEKINIST, alone or in combination with TAFINLAR, can cause inflammation

of the intestines or tears in the stomach or intestines that can lead to

death. Patients should report to their health care provider immediately

if they have any of the following symptoms: bleeding, diarrhea (loose

stools) or more bowel movements than usual, stomach-area (abdomen) pain

or tenderness, fever, or nausea.

TAFINLAR, in combination with MEKINIST, can cause blood clots in the

arms or legs, which can travel to the lungs and can lead to death.

Patients should be advised to get medical help right away if they have

the following symptoms: chest pain, sudden shortness of breath or

trouble breathing, pain in their legs with or without swelling, swelling

in their arms or legs, or a cool or pale arm or leg.

The combination of TAFINLAR and MEKINIST can cause heart problems,

including heart failure. A patient's heart function should be checked

before and during treatment. Patients should be advised to call their

health care provider right away if they have any of the following signs

and symptoms of a heart problem: feeling like their heart is pounding or

racing, shortness of breath, swelling of their ankles and feet, or

feeling lightheaded.

TAFINLAR, in combination with MEKINIST, can cause severe eye problems

(MORE TO FOLLOW) Dow Jones Newswires

May 29, 2020 08:00 ET (12:00 GMT)