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.

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.