In a world now brim­ming with check­point in­hibitors, com­pa­nies of­ten strug­gle to make a mark giv­en a raft of ther­a­pies have al­ready cap­tured a con­sid­er­able por­tion of the vast on­col­o­gy mar­ket.

BeiGene’s tislelizum­ab was the fourth PD(L)-1 in­hibitor to se­cure ap­proval in Chi­na — and as it works on ex­pand­ing its share the com­pa­ny has put out de­tailed da­ta on the use of the drug in cer­tain pa­tients with lung can­cer.

On­ly last month did BeiGene un­veil that tislelizum­ab in com­bi­na­tion with stan­dard chemother­a­py fared bet­ter than chemo alone as the first line of de­fense in pa­tients with ad­vanced squa­mous non-small cell lung can­cer (NSCLC). On Fri­day, as part of the key can­cer con­fer­ence Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy (AS­CO), the Chi­na-based drug­mak­er dis­closed the num­bers.

The 360-pa­tient tri­al, which test­ed the check­point in­hibitor with two dif­fer­ent chemo reg­i­mens against chemo alone, showed that the me­di­an time dur­ing which pa­tients did not see dis­ease pro­gres­sion in the tislelizum­ab com­bo groups was 7.6 months ver­sus 5.5 months for chemo alone.

Ob­jec­tive re­sponse rates were al­so “mean­ing­ful­ly high­er” — be­tween 73% and 75% in the tislelizum­ab groups, ver­sus 50% in the chemo alone arm. In ad­di­tion, treat­ment with the BeiGene drug al­so rough­ly dou­bled the me­di­an du­ra­tion of re­sponse com­pared to chemother­a­py alone: 8.2 months and 8.6 months for the two tislelizum­ab groups, ver­sus 4.2 months for the chemo arm.

Tislelizum­ab was first ap­proved in Chi­na in late 2019 for clas­si­cal Hodgkin’s lym­phoma and then lat­er for metasta­t­ic urothe­lial car­ci­no­ma pa­tients. The drug marked a key mile­stone in the coun­try — the first in­stance of a for­eign part­ner pro­duc­ing a mar­ket­ed drug un­der a re­formed con­tract man­u­fac­tur­ing reg­u­la­to­ry sys­tem. BeiGene’s part­ner in this case is Ger­many’s Boehringer In­gel­heim, which is sup­ply­ing the PD-1 an­ti­body for com­mer­cial use us­ing a Shang­hai fa­cil­i­ty.

The ap­proval of tislelizum­ab in late 2019 was rough­ly a year af­ter the first ap­proval by Jun­shi for Tuoyi. In­novent’s Tyvyt and Mer­ck’s flag­ship Keytru­da were ush­ered in af­ter.

Tislelizum­ab, de­spite the crowd­ed land­scape, has had an en­cour­ag­ing launch. In the first quar­ter of 2020, the drug gen­er­at­ed about $52 mil­lion in sales, best­ing con­sen­sus ex­pec­ta­tions of $47 mil­lion, SVB Leerink’s An­drew Berens wrote in a note ear­li­er this month. He lift­ed his mar­ket share ex­pec­ta­tions for tislelizum­ab in Chi­na, vault­ing his in peak sales ex­pec­ta­tions to $768 mil­lion, up from $461 mil­lion pre­vi­ous­ly.

Da­ta from the non-squa­mous NSCLC pa­tient piv­otal study have al­ready been dis­closed, and the Chi­nese reg­u­la­tor is cur­rent­ly re­view­ing an ap­pli­ca­tion to mar­ket the drug in NSCLC pa­tients. Mean­while, in 2020 or ear­ly 2021, the com­pa­ny ex­pects to re­veal topline re­sults from a glob­al late-stage tri­al com­par­ing tislelizum­ab ver­sus do­c­etax­el in sec­ond and third-line NSCLC pa­tients as well as da­ta from the Phase 3 tri­al com­par­ing tislelizum­ab ver­sus chemother­a­py in sec­ond-line ad­vanced esophageal squa­mous-cell car­ci­no­ma pa­tients.

Mean­while, akin to pret­ty much every oth­er check­point in­hibitor mak­er, BeiGene is ex­plor­ing the use of its of­fer­ing in com­bi­na­tion with oth­er treat­ments. On­ly days ago, it said it would be test­ing two of part­ner Chi-Med’s drug can­di­dates, su­r­u­fa­tinib and fruquin­tinib, in com­bi­na­tion with tislelizum­ab, for the treat­ment of var­i­ous sol­id tu­mor can­cers, in the US, Eu­rope, Chi­na and Aus­tralia.

So­cial: Ma Luyao via Wiki­me­dia

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.