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.

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.