Will Poziotinib Overcome the 20% Probability as the 'Day of Destiny' Approaches...

Hanmi Pharmaceutical's Non-Small Cell Lung Cancer New Drug
FDA Approval Decision Deadline on the 24th

Previous Advisory Committee Gave Negative Conclusion
"Only 20% Approval After Negative Conclusion"

Molecular structure image of Poziotinib

[Asia Economy Reporter Lee Chun-hee] The decision on the U.S. approval of Hanmi Pharmaceutical's non-small cell lung cancer treatment new drug 'Poziotinib' will be made today. However, with negative opinions emerging from the advisory committee and analyses suggesting the approval probability is only 20%, attention is focused on whether Hanmi Pharmaceutical can succeed in obtaining FDA approval in the U.S. for the second consecutive time.

On the 24th (local time), the deadline for the FDA's decision on the marketing approval of Poziotinib under the Prescription Drug User Fee Act (PDUFA) arrives. Hanmi Pharmaceutical is aiming for back-to-back approvals following the FDA approval of the neutropenia treatment 'Rolontis' in September.

Poziotinib is a pan-HER2 anticancer agent that Hanmi Pharmaceutical licensed in 2015 to the U.S. company Spectrum Pharmaceuticals, which had previously licensed Rolontis. It was developed as a second-line treatment for HER2 exon 20 mutation lung cancer patients, for whom no formally approved treatment exists. Spectrum submitted a New Drug Application (NDA) to the FDA in December last year.

However, in September, the FDA Oncology Drug Advisory Committee (ODAC) voted 9 to 4 that the benefits of Poziotinib do not outweigh the risks. ODAC is an independent advisory committee composed of experts who review and evaluate data on the efficacy and safety of anticancer drugs. ODAC strongly expressed concerns about Poziotinib's efficacy, stating, "If granted accelerated approval, this would be the least effective targeted therapy for lung cancer approved to date."

Portion of the briefing document from the U.S. Food and Drug Administration (FDA) Oncology Drugs Advisory Committee (ODAC) mentioning the efficacy of Hanmi Pharmaceutical's non-small cell lung cancer treatment 'Pogziotinib'

ODAC raised doubts about Poziotinib's efficacy, citing its objective response rate (ORR) of about 28%, which is low. They compared it to AstraZeneca-Daiichi Sankyo's antibody-drug conjugate (ADC) anticancer new drug 'Enhertu,' which has an ORR of 58%. They also pointed out that the median duration of response (mDoR) for Poziotinib is 5.1 months, lower than Enhertu's 8.7 months.

Furthermore, ODAC viewed safety concerns as significant. Among 368 patients receiving 16 mg once daily of Poziotinib, grade 3-4 adverse events occurred in 85%, and dose reductions were required in 57%, indicating a low drug tolerance in terms of safety profile. While the advisory committee noted that such side effects might be mitigated in alternative dosing groups, they mentioned that further analysis is needed regarding the efficacy at this dosage.

In response, Hi Investment & Securities stated in a report that "the probability of FDA approval success for Poziotinib, a targeted therapy for non-small cell lung cancer, has decreased." The reason is that only about 20% of cases have overturned negative advisory committee opinions to achieve FDA approval. Hi Investment & Securities downgraded Poziotinib's success probability from 85% to 20% and lowered the new drug's valuation from 140 billion KRW to 38 billion KRW.

Hanmi Pharm Headquarters Exterior (Photo by Hanmi Pharm)

Hanmi Pharmaceutical and Spectrum emphasized that considering the securing of various treatment options and the benefit-risk balance, Poziotinib has utility. Hanmi Pharmaceutical is reportedly strongly presenting to the FDA the usefulness of Poziotinib based on the high mortality rate of lung cancer and the need for diverse treatment options, including its potential as a second- or third-line therapy.

Daishin Securities also analyzed, "Poziotinib is an oral drug, offering greater dosing convenience compared to existing injectable therapies," and "it can be an additional treatment option for patients with high unmet needs, so we maintain the valuation of the new drug." However, regarding the possibility of approval this time, they added, "Given the high proportion of opposing opinions, additional data on efficacy and safety through follow-up clinical trials will be necessary."

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