Jazz Is within the “Goldilocks Zone” With New Most cancers Knowledge at ASCO25

Rob Iannone confirmed me the ASCO 2025 identify tag he’s sporting. Under the road the place it says “Jazz Prescription drugs” is an enormous yellow stripe saying that Iannone has been a member of the American Society of Medical Oncology for 1 / 4 of a century.

“I’ve been coming to ASCO for 25 years; that offers you a touch about my age,” he says with a sly smile. When he started attending the annual assembly in 2000, Iannone was a pediatric oncologist. “In that point, I’ve handled sufferers with high-grade gliomas. Debulking surgical procedures and radiation remedy was customary of care again then,” he mentioned. “Right here we’re 25 years later, and the usual of care is debulking surgical procedure and radiation.”

Iannone, chief medical officer at California-based Jazz, is hoping {that a} new molecule may change that. Acquired in Jazz’s $935 million buy-out of Chimerix in March, dordaviprone is a multi-target small molecule for pediatric gliomas, a very aggressive and lethal mind most cancers. Jazz was intrigued sufficient to pay a 72% premium on Chimerix’s inventory to get its palms on the molecule, which has an FDA PDUFA date of August 18.

Jazz is at ASCO to current, amongst different issues, new efficacy and security knowledge from a Section II trial of dordaviprone. Whereas the drug’s particular indication (H3K27 mutated gliomas) is uncommon—affecting round 5,000 sufferers worldwide, based on Truist analysts writing on the time of the Chimerix deal— the potential applicability of the dordaviprone is way broader. Truist modeled a possible $800 million in yearly gross sales by 2037 for the drug, and famous that its mechanism of motion may make it worthwhile for different cancers past gliomas.

The Chimerix deal additionally introduced with it a next-generation model of dordaviprone, termed ONC206, with an identical mechanism and better efficiency in vitro.

Iannone mentioned he’s satisfied with the outcomes of the acquisition, noting that it “suits in properly” with Jazz’s general pipeline technique of in search of areas of unmet wants. And Jazz is an effective match for successfully bringing dordaviprone and its successor to the market, Iannone mentioned.

Earlier in his profession, Iannone bounced from a professorship in pediatrics, oncology and bone marrow transplantation on the College of Pennsylvania to work at Merck, the place he contributed to the event of the mega blockbuster Keytruda. “I used to be on the proper place on the proper time” he mentioned about his time on that mission. He then had stints at AstraZeneca and Immunomedics earlier than coming to Jazz six years in the past. In comparison with the tens of hundreds of workers marshalled by Merck and AstraZeneca, Jazz employs a modest 3,000–3,500 folks, about 800 of that are in analysis and improvement.

“We’re slightly little bit of a Goldilocks measurement,” Iannone mentioned. “We have now all of the assets we have to accomplish our targets. We’re sufficiently small that we don’t get in our personal approach. That makes us a positive partnership, persons are shocked at we are able to do as companions.”

He famous ease of entry as one instance. “After we’re discussing acquisitions or licensing, firms have direct entry to folks like me, which is likely to be tougher at a much bigger firm.”

That ease of liaising with different firms has introduced Jazz a few of its lead molecules, Iannone mentioned. Notably, Jazz licensed its small molecule therapeutic Zepzelca from PharmaMar in 2021 for a scant $5 million up entrance plus as much as $3 million in gross sales milestones, in addition to tiered royalties.

Along with its presentation on dordaviprone, Jazz is in Chicago this week to current new knowledge from the Section III IMforte trial of Zepzelca together with Roche’s Tecentriq in small cell lung most cancers. Including Zepzelca to Roche’s PD-1 inhbitor improved sufferers’ median survival by 4 months in contrast with Tecentriq alone (17 months versus 13 months, based on Iannone), whereas decreasing sufferers’ threat of loss of life by 27%.

Most encouraging was a tolerable security profile. The combo routine principally resulted in neutropenia, which Iannone mentioned will be managed and is a stable trade-off for sufferers who would in any other case face a tough chemotherapy routine.

The same old therapy routine includes 4 to 6 cycles of chemo, Iannone defined. “Most sufferers don’t make it to 6, possibly they get to 4. Toxicity is such that sufferers cease, and doubtlessly proceed on with anti-PD-1 remedy alone. Survival after sufferers cease chemo drops quickly, Iannone added. Outcomes from IMforte point out that Zepzelca might signify a extra palatable possibility.

The businesses have already filed a BLA for the combo however the FDA has but to set a PDUFA date. With the brand new survival knowledge in hand, “I’d count on to get precedence evaluation, which might permit us to get an approval this yr,” Iannone mentioned.