Leg­end Biotech has has a good three years ever since the then-lit­tle known biotech un­veiled a round of BC­MA CAR-T da­ta at AS­CO. It helped net them a part­ner­ship with J&J and, more re­cent­ly, one of biotech his­to­ry’s biggest IPOs.

Now, the Nan­jing-based biotech un­veiled their largest set of da­ta for the ther­a­py, show­ing in­ter­im re­sults from a piv­otal US study con­duct­ed with J&J. The da­ta af­firmed the drug’s now well-doc­u­ment­ed ef­fi­ca­cy, with a 94% re­sponse rate and a 55% com­plete re­sponse rate, but it al­so re­vealed that, out of 97 pa­tients in the study, 10 died.

Eight of the deaths were from ad­verse events — whether re­lat­ed or un­re­lat­ed — and two were from dis­ease pro­gres­sion. No­tably, though, on­ly one death was from cy­tokine re­lease syn­drome, the in­flam­ma­to­ry con­di­tion that has dogged CAR-T since the first ex­per­i­men­tal ther­a­pies were put in­to hu­mans.

Leg­end dis­closed the CRS death, along with two oth­ers, in their S-1 this spring.

The com­pa­ny al­so not­ed a 20.6% rate of neu­ro­tox­i­c­i­ty, an­oth­er com­mon dan­ger­ous CAR-T side ef­fect. Af­ter the last cut of da­ta in 29 pa­tients in De­cem­ber, they had said “neu­ro­tox­i­c­i­ty was in­fre­quent­ly ob­served.”

Of course, se­vere side ef­fects have not al­ways held up CAR-T treat­ments in the past, par­tic­u­lar­ly when they al­so brought com­pelling ef­fi­ca­cy da­ta, and the J&J in­ves­ti­ga­tors said the da­ta were “con­sis­tent” with pri­or stud­ies. No­var­tis, for in­stance, saw 3 deaths in its piv­otal study for Kym­ri­ah and more than half of its pa­tients ex­pe­ri­ence neu­ro­log­i­cal symp­toms.

Safe­ty splits could be­come par­tic­u­lar­ly rel­e­vant, though, as J&J seeks to go head-to-head with the ri­val mul­ti­ple myelo­ma CAR-T treat­ment from blue­bird and Bris­tol My­ers Squibb, which is al­ready sit­ting be­fore the FDA.

In their most re­cent phase II da­ta, blue­bird sim­i­lar­ly saw one CRS-re­lat­ed death out of 140 pa­tients, but didn’t dis­close oth­er deaths in the tri­al. They re­port­ed that 3.1% of pa­tients had grade 3 or high­er neu­ro­tox­i­c­i­ties.

That da­ta set al­so showed re­duced ef­fi­ca­cy com­pared to what Leg­end showed in to­day’s cut, con­tin­u­ing a trend since AS­CO 2017. (Blue­bird main­tained at the time that Leg­end chose eas­i­er pa­tients). They saw an 81.5% re­sponse rate in the high­est per­form­ing dose group, with 35.2% see­ing some form of com­plete re­sponse.

J&J wasn’t yet able to col­lect du­ra­tion of re­sponse da­ta, but they showed that one pa­tient has re­spond­ed for around 20 months. Of pa­tients who were fol­lowed for 6 months, 87.4% had not seen their can­cers progress at that time and 93.8% were still alive.

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.

Roche has another stack of data to back up its longer-acting challenger to Eylea — although it’s still far from certain just how much they can threaten Regeneron’s dominance.

The latest Phase III results come from two trials that enrolled 1,329 patients with neovascular age-related macular degeneration. With 45% of people in both studies getting faricimab 16 weeks apart during the first year, the bispecific still induced the same level of gains in visual acuity as Eylea every 8 weeks did, Roche’s Genentech reported.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.