Months af­ter the FDA sanc­tioned the ap­proval of Roche’s run­ner up check­point in­hibitor Tecen­triq in com­bi­na­tion with Cel­gene’s Abrax­ane for treat­ment naive pa­tients with triple neg­a­tive breast can­cer, Mer­ck’s keynote PD-1 Keytru­da has stum­bled in a late-stage tri­al as the sec­ond or third line of de­fense against the rare, ag­gres­sive form of can­cer.

Pa­tients in the 622-pa­tient tri­al were ei­ther giv­en the block­buster treat­ment or chemother­a­py. The main goal of the study — over­all sur­vival — was not met, Mer­ck said, adding that de­tails will be dis­closed at a lat­er date.

The US drug­mak­er will con­tin­ue to test Keytru­da monother­a­py and in com­bi­na­tion with chemother­a­py in ear­li­er stages of the dif­fi­cult-to-treat dis­ease.

About 10-20% of all breast can­cers are triple-neg­a­tive breast can­cers (TNBCs), which char­ac­ter­is­ti­cal­ly has a high re­cur­rence rate with­in the first five years af­ter di­ag­no­sis. In TNBC pa­tients, the growth of the can­cer is not fu­eled by the hor­mones es­tro­gen and prog­es­terone, or by the HER2 pro­tein, mak­ing it hard to treat.

Roche’s Tecen­triq com­bi­na­tion with Abrax­ane was the first-ever im­munother­a­py to get ap­proval in the first­line TNBC set­ting. The ap­proval was key for the Swiss drug­mak­er that is third-in-line — be­hind Bris­tol-My­ers Squibb and Mer­ck — for the check­point in­hibitor Iron throne. The large drug­mak­er must get ahead of its ri­vals in cru­cial can­cer ar­eas if it wants to hold on to its po­si­tion, as As­traZeneca carves out a niche for its PD-L1 check­point Imfinzi in a sub­set of non-small cell lung can­cer pa­tients.

About 70% of breast can­cers di­ag­nosed in peo­ple with an in­her­it­ed BR­CA mu­ta­tion, par­tic­u­lar­ly BR­CA1, are di­ag­nosed with TNBC. PARP in­hibitors such as As­traZeneca’s Lyn­parza and Pfiz­er’s Talzen­na are al­ready ap­proved for germline BR­CA-mu­tat­ed breast can­cer, and are be­ing in­ves­ti­gat­ed in com­bi­na­tion with check­point in­hibitors for TNBC.

Mean­while, an­ti­body drug con­ju­gates are an­oth­er po­ten­tial treat­ment op­tion for TNBC un­der in­ves­ti­ga­tion.

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.