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.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.