UK's NICE is­n't con­vinced by Mer­ck­'s Keytru­da in head and neck can­cer

There may be 33 new cas­es of head and neck can­cer in the Unit­ed King­dom each day, but the re­gion’s cost-ef­fec­tive­ness watch­dog NICE is not con­vinced by the da­ta sup­port­ing Mer­ck’s flag­ship im­munother­a­py Keytru­da in the pa­tient pop­u­la­tion.

On Wednes­day the agency said it was not rec­om­mend­ing Keytru­da for pa­tients with un­treat­ed metasta­t­ic or un­re­sectable re­cur­rent head and neck squa­mous cell car­ci­no­ma (HN­SCC), cit­ing un­cer­tain­ty that the tri­al ev­i­dence sup­port­ing the drug does not re­flect the cur­rent treat­ment par­a­digm in Eng­land’s NHS.

The ap­proval for Keytru­da in HN­SCC pa­tients was based on da­ta from the KEYNOTE-048 study, which showed the check­point in­hibitor im­proved over­all sur­vival com­pared to ce­tux­imab (Er­bitux), plat­inum chemother­a­py (cis­platin or car­bo­platin) and 5-Flu­o­rouracil (5-FU). The haz­ard ra­tio was 0.78 (p=0.0171) for PD-L1 pos­i­tive pa­tients in the monother­a­py group and 0.77 (p=0.0067) for the en­tire com­bo co­hort.

In the com­para­tor arm, pa­tients were giv­en ce­tux­imab with plat­inum chemother­a­py and 5-FU re­gard­less of whether the can­cer start­ed in­side or out­side the mouth — this is not es­tab­lished clin­i­cal prac­tice in the NHS in Eng­land, NICE said.

(If the can­cer starts in­side the mouth, NHS Eng­land treats with ce­tux­imab, plat­inum chemother­a­py and 5-FU — if it starts out­side the mouth, the can­cer is ini­tial­ly treat­ed with plat­inum chemother­a­py and 5-FU).

NICE was look­ing for ev­i­dence of Keytru­da’s im­pact strat­i­fied by pa­tients whose can­cer be­gan out­side the mouth and said that in­for­ma­tion about the clin­i­cal and cost-ef­fec­tive­ness for the two dif­fer­ent pa­tient groups (can­cer start­ing in­side or out­side the mouth) was in­com­plete.

The drug se­cured EU ap­proval for head and neck can­cer last No­vem­ber. There are around 11,900 new head and neck can­cer cas­es in the UK every year, that’s 33 every day, ac­cord­ing to es­ti­mates com­piled by Can­cer Re­search UK be­tween 2014-2016.

Keytru­da is how­ev­er rec­om­mend­ed for a range of oth­er can­cers by NICE, on the ba­sis that Mer­ck agreed to a con­fi­den­tial dis­count on the block­buster’s list price of £2,630 per 100 mg vial.

Sep­a­rate­ly, NICE al­so did not en­dorse Astel­las Phar­ma’s can­cer drug, Xospa­ta, in pa­tients with re­lapsed or re­frac­to­ry FLT3 mu­ta­tion-pos­i­tive acute myeloid leukemia (AML).

Al­though the ev­i­dence sug­gests that Xospa­ta can in­crease life ex­pectan­cy by more than three months ver­sus ex­ist­ing treat­ments, there is un­cer­tain­ty around long-term sur­vival, NICE said, adding that its cost-ef­fec­tive­ness es­ti­mates are al­so above the range the NHS con­sid­ers ac­cept­able.

The list price for Xospa­ta is £14,188 for a 28-day pack — but a con­fi­den­tial dis­count is in place for the NHS. The drug scored EU ap­proval in this pa­tient pop­u­la­tion last Oc­to­ber.

In ad­di­tion, NICE did back As­traZeneca’s Lyn­parza in adults who have re­lapsed plat­inum-sen­si­tive ovar­i­an, fal­lop­i­an tube or peri­toneal can­cer with a BR­CA1 or BR­CA2 mu­ta­tion.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Ken Frazier, AP Images

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Mark Genovese (Stanford via Twitter)

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Federico Mingozzi (Spark)

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