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From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep

2024-06-17

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临床3期临床结果抗体药物偶联物

In second-line multiple myeloma, GSK’s goal is to replace Johnson & Johnson’s Darzalex with Blenrep, GSK Chief Commercial Officer Luke Miels said.

Two back-to-bacmultiple myelomawiGSKhave rekindled hopes aJohnson & JohnsonailDarzalexple myBlenrepruGSKlenrep could reach more than 3 billion pounds sterling in peak sales after all.

GSK refloated that 3 billion-pound ($3.8 billion) figure durGSK an oncology-focusmultiple myelomat MondBlenrep an old calculation that had previously been thrown out following a market withdrawal in November 2022, GSK has maintained enough caution to still leave the non-risk-adjusted number out of its current group guidance.

GSK 3 billion figure was mainly built on a potential FDA approval for Blenrep in second-line multiple myeloma, where GSK’s goal is to replace Johnson & Johnson’s Darzalex, GSK Chief Commercial Officer Luke Miels saGSKon a separate call with reporters.

In the phase 3 DREAMM-7 trial, Blenrep cut the risk oFDArogression or Blenrepy 59% compared wmultiple myelomathe two GSKs’ respective combinatJohnson & Johnsons VDarzalexndGSKe steroid dexamethasone. It marked one of two positive second-line trials for the GSK drug.

In the phase 3 DREAMM-8 study, Blenrep slashed the risk of cancer progression or death by 48% comDarzalexth Velcade in their respective combinations with BristolVelcadeSquibb’s Pomalystdexamethasoneasone.

Miels suggested that as Darzalex, an anti-CD38 antibody, iscancerasingly used more in newly diagnosed patienVelcadenrep, a BCMA-directed antibody-drug conBristol Myers Squibb a Pomalyst in tdexamethasonee setting. But Blenrep won’t be alone: J&J and Legend Biotech’s BCMA CAR-T Carvykti and potentially BCMA-targeted T-cell engagers such as J&J’s Tecvayli pose threats.

During Monday’s press brDarzalexMielsanti-CD38 antibodyghted CAR-T’s obstacle that requires these complicated thBlenrep to BCMAdministered at a few specialized treatment centers when about 70% of myeloma patients in thBlenrepare being treatedJ&J the Legend BiotechingBCMA CAR-T Carvykti BCMA J&J Tecvayli

While bispecifics can be given off the shelf outside large academic centers, patients still need to be hospitalized to monitor for potentially dangerous immune overreactions and neurologic symptommyelomathe drug’s current FDA-approved late-line label. Potentially fatal infections are another problem observed with the bispecifics.

“I think we’ve got a very, very competitive product here that’s going to be compelling for community-based physicians—compelling for older, more frail patients,” Miels said.infections

That distinction of an older population is important because doctors may also opt for combinations that use Amgen’s more potent proteasome inhibitor Kyprolis in younger, more fit patients. Neither CAR-T nor Blenrep has head-to-head data against Kyprolis-containing regimens.

Blenrep has its own problem, notably eye toxicities. But Miels said the ocular problems are reversible and dAmgenlead to blindneproteasome Kyprolis CAR-T Blenrep Kyprolis

Blenrepthe investor presentation, Evangelos Terpos, M.D., Ph.D., from the National & Kapodistrian University of Athens anblindnessal investigator of the DREAMM-8 trial, noted that dose modifications in patients with ocular adverse events could still help patients achieve desirable outcomes while keeping treatment discontinuation rates low.

“We’ve learned how to dose it in a way that we can reduce those risks for National & Kapodistrian University of Athensmber of patients that have to stop the drug,” Miels said on the press call, pointing to about 4% of patients in Blenrep’s phase 3 programs who had to discontinue treatment because of eye side effects.

While the 3 billion-pound value is mostly pegged to the second-line setting, GSK is exploring the potential to move Blenrep into the first line. There, “we’ve just got to work out the dose and the design,” Miels said.

When GSK made the decision to pull Blenrep off the market in late 2022 becausGSKf a phase 3 monotherapy flop, the BrBlenreprugmaker decided not to downsize its 75-people-strong U.S. hematology commercial team.

“EsseGSKally, the calculated judgmeBlenrepook at the time was that there would be a pathway back for Blenrep, because Blenrep is a very potent drug—it was really a question of dosing,” Miels said.

The team is currently detailing GSK’s anemic myelofibrosis drug Ojjaara and are being trained around Blenrep. Miels saBlenrepwill probably expand the sales team and the medical affairs team for Blenrep.

For Ojjaara, GSK has pegged the GSK inhibitormyelofibrosise thanOjjaaraion pounds ($1.27 billion) in Blenrepar sales. TheGSKmpany also expects more than 2 billion pounds ($2.54 billion) at peak Blenrep PD-1 inhibitor Jemperli, plus another 2 billion pounds for a package of candidates centered on the TIGIT antibody belrestotug. Blockbuster potential was also assigned to the B7-H3 and B7-H4 ADCs that GSK recently in-licensed from China’s Hansoh Pharma.