CG On­col­o­gy has been qui­et­ly chug­ging along — on­ly giv­ing up­dates at se­quen­tial can­cer con­fer­ences ahead of a full read­out on its on­colyt­ic virus can­cer ther­a­py next year.

In its lat­est at SITC, the Irvine, CA-based biotech showed up with longer-term da­ta on its ther­a­py, CG0070, in com­bi­na­tion with Mer­ck’s Keytru­da. While the da­ta are still ear­ly, they sug­gest more dura­bil­i­ty where the biotech had ini­tial­ly turned heads on ef­fi­ca­cy.

The biotech is test­ing its ther­a­py in pa­tients with non-mus­cle in­va­sive blad­der can­cer who did not re­spond to stan­dard BCG ther­a­py. Of 32 pa­tients, 28 had no signs of can­cer at the 3-month fol­low-up. Go­ing out to 6 months, that num­ber changes to 25 of 29. And at one year, the pri­ma­ry end­point of the study, 11 of 15 pa­tients had a com­plete re­sponse to treat­ment — good for a 73% re­sponse rate.

Roger Li

That adds two non-re­spon­ders to the com­bo ther­a­py since CG’s last up­date at AS­CO in June, but of the pa­tients who had a com­plete re­sponse at three months, while some have had dis­ease re­cur­rence, none have seen their dis­ease progress, lead in­ves­ti­ga­tor Roger Li told End­points News. He al­so not­ed that of the two pa­tients with two years’ fol­low-up at his site, Mof­fitt Can­cer Cen­ter, both still have com­plete re­spons­es.

CG On­col­o­gy CEO Arthur Kuan not­ed that while the da­ta are still ear­ly, they seem promis­ing thus far, and the biotech is plan­ning ad­di­tion­al tri­als for the on­colyt­ic virus treat­ment. The cur­rent tri­al is ful­ly en­rolled, and Kuan said that the biotech plans to read out the full da­ta on the com­bo ther­a­py at a ma­jor can­cer con­fer­ence some­time next year. The biotech is al­so test­ing the treat­ment as a monother­a­py in a Phase III tri­al, but re­sults are still a bit away, as the study won’t have topline da­ta un­til 2024, ac­cord­ing to clin­i­cal­tri­als.gov.

Li said that one of the non-re­spon­ders had a case of un­di­ag­nosed lym­phoma at the time of en­roll­ment, of which they don’t know the im­pact on the pa­tient’s re­sponse to treat­ment.

In terms of safe­ty, the most com­mon ad­verse re­ac­tions were blad­der-re­lat­ed, such as fre­quent uri­na­tion, Li said. There was one case of grade three im­mune-me­di­at­ed he­pati­tis and three cas­es of hy­per­thy­roidism, which Li not­ed are in line with the side ef­fects of Keytru­da. “We don’t think that adding on CG0070 re­al­ly adds too much to the sys­temic tox­i­c­i­ty pro­file,” he said of the safe­ty of the treat­ment over­all.

The US Solicitor General is calling on the Supreme Court to take up a fiercely debated case that could have a chilling effect on generic drug companies’ willingness to bring their copycats to market under so-called “skinny” labels, meaning the generic can only be approved for some of the reference product’s indications.

The case in question relates to GSK’s win over Teva in a long-running battle over the generic giant’s skinny label for GSK’s beta-blocker Coreg (carvedilol). At the time in 2007, Teva’s generic label first included two of the three Coreg indications, but Teva did not initially win approval for the third indication for congestive heart failure.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.