Health Care

Halts Enrollment in Two Keytruda Trials, Citing Deaths

Halts Enrollment in Two Keytruda Trials, Citing Deaths”

The pause in recruitment follows an external Data Monitoring Committee making the recommendation based on a review of the data showing an increased number of deaths observed in the clinical studies.

Merck & Co said on Monday it paused enrolments in two late-stage studies testing its immunotherapy drug Keytruda used in combination with other therapies to treat multiple myeloma, a type of blood cancer. The trials involve combinations with Celgene's Pomalyst as well as its flagship drug Revlimid in a field Celgene dominates in.

Merck shares were down 1 percent to $63.75 in trading after the markets close in NY.

Keynote-183 is examining a regimen combining Keytruda, low-dose dexamethasone and Celgene's Pomalyst (pomalidomide) in patients with relapsed or refractory multiple myeloma.

The other Phase III study, KEYNOTE-185, is created to compare the combination of lenalidomide and low-dose dexamethasone plus Keytruda to lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant (autoSCT).

Keytruda is a keystone drug for Merck. In May, the U.S. Food and Drug Administration expanded Keytruda's use by approving it for two new bladder cancer options. Keytruda is an antibody directed towards the programmed cell death protein 1 (PD-1) located on lymphocytes.

Keytruda is also approved for the treatment of patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

BMS' Opdivo, as well as Genentech (RHHBY)'s PD-1 inhibitor Tecentriq, have seen their share of troubles. In May, Merck KgaA (MKGAF.PK) and Pfizer saw approval for Bavencio.



Like this

loading...
loading...

Latest


26 June 2017
Such incidents should be stopped at earliest: Brinda Karat on Ballabhgarh lynching
As per reports, what was initially an argument over seats soon turned communal after the mob found out that they were Muslims. The Hindustan Times quoted the man , the only accused to have been arrested so far, as saying, "I was drunk".

26 June 2017
Google, YouTube to introduce new measures to tackle extremist content online
In a statement, Google said such content "poses a serious challenge and more immediate action needs to be taken". Alphabet's Jigsaw group has previously run experiments on YouTube with what it calls the Redirect Method .

26 June 2017
Saudi Arabia Rewrites Succession as King Replaces Heir With Son, 31
Prince Abdulaziz bin Saud, 33, was named the new interior minister tasked with counterterrorism efforts and domestic security. The king then has the right to choose his own successor and this person doesn't necessarily have to be his son.

26 June 2017
Donald Trump's son seems to confirm James Comey's account of Flynn investigation
Donald Trump shakes hands with his Romanian counterpart Klaus Iohannis after a joint news conference in the Rose Garden on Friday. The tweet broke a mysterious period of silence on social media for the President, who until then had not tweeted since June 7.

26 June 2017
Morgan defends dropping himself for SA finale
Malan, who will turn 30 in just over two months, admitted he thought his chance of playing global cricket may have gone. Crane's third over went 4, 6, 6, 1, 1 before de Villiers was caught above his head by Alex Hales at deep square leg.

26 June 2017
Cable car crashes in tourist resort in Kashmir, killing 7
She has also directed conducting of a high level inquiry to know of the causes or lapses, if any, that led to the accident. It is the world's second highest operating cable vehicle project with a cabin capacity of ferrying 600 people in one hour.

26 June 2017
As Corbyn rises, May comes under fire; others in shock
British politicians, including within May's own party, differ widely on what they want from the Brexit negotiating process. Her predecessor, David Cameron, first asked British voters to decide in 2016 whether to leave the EU.

26 June 2017
Rafael Nadal withdraws from the Aegon Championships — ATP Queen's
Nadal fell to Federer in two of the three title matches, but on the red dirt in Europe, the Spaniard has been almost ideal . It was a steamy day in Paris - temperatures hovered around 30 degrees Celsius - a boost to Nadal's heavily spun forehand.

26 June 2017
Family of Sam DuBose demands another retrial, calls for peaceful protest
Prosecutors broke down body camera video frame-by-frame to rebut Tensing's assertion that he was being dragged down the street. The prosecution argued Tensing was in no imminent danger but rather forgot his training and reacted in an unreasonable manner.

26 June 2017
Manchester United FC reach agreement to sign Benfica defender Victor Lindelof
With Benfica, Lindelof won three Primeira Liga titles and was named to the UEFA Champions League "Breakthrough XI" in 2016. We are pleased to announce we have reached agreement with Benfica for the transfer of Victor Lindelof.