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# Iovance Lung Cancer Subgroup Hits 59.1% Response Rate, But Broader Group Reaches Only 24.6%
- URL: https://www.bullished.co/iovance-lung-cancer-subgroup-hits-59-1-response-rate-but-broader-group-reaches-only-24-6-ed484d87/
- Published: 2026-10-29T21:05:58.000Z
- Updated: 2026-11-02T00:05:37.000Z
- Description: Iovance plans to test a biomarker-selected approach in a new cohort enrolling in November after responses clustered in one subgroup.
- Author: Matteo Parrino
- Tags: SEC Filings, IOVA, Industry: Healthcare

[Iovance Biotherapeutics](https://www.bullished.co/tag/iova/), which develops cell therapies for solid tumors, said [17 of 69 previously treated patients](https://www.sec.gov/Archives/edgar/data/0001425205/000110465926120261/tm2628468d1%5F8k.htm?ref=bullished.co) with non-squamous lung cancer responded to lifileucel, a 24.6% response rate. A retrospective analysis found most of those responses concentrated in a 22-patient subgroup, where the rate reached 59.1%.

## Where the responses clustered

The data cutoff was October 14, 2026, and the [24.6% rate](https://www.sec.gov/Archives/edgar/data/0001425205/000110465926120261/tm2628468d1%5Fex99-1.htm?ref=bullished.co) is in line with the 25.6% reported earlier in 39 patients. Of the 17 responses, 15 were confirmed and two were unconfirmed partial responses awaiting confirmation. An independent committee's radiologic review is still under way.

Patients with KRAS wild-type tumors responded at 43.3% (13 of 30), against 11.4% (4 of 35) for KRAS-mutant disease. Both complete responses were in the wild-type group. Four patients whose KRAS status was not assessed are excluded.

Adding HER2 wild-type status brought the rate to 52.0% (13 of 25). Adding current or former smoking gave 59.1% (13 of 22). That subgroup was 31.9% of the study population but produced 76.5% of the responses.

The subgroup was defined after the fact. Patients were enrolled without selection on these criteria.

## A biomarker-selected trial in November

Iovance will test the approach prospectively in POSITILITY, a cohort within IOV-LUN-202 with registrational intent, subject to FDA feedback. Enrollment is to begin in November 2026 at the first of more than 70 existing trial sites.

The broader cohorts are completing enrollment, with about 80 non-squamous patients expected in the final dataset. Iovance plans a supplemental license application for lifileucel in non-squamous disease in 2027, and discussions with the FDA are ongoing.

Interim CEO Frederick Vogt said the findings are "reshaping how we develop TIL therapy for mNSCLC." The company estimates the biomarker-enriched population at about 45% of non-squamous cases diagnosed each year in the US.

## A small frontline signal

In a separate frontline cohort, six of seven patients with the matching biomarkers responded to lifileucel plus pembrolizumab, an 85.7% rate, without chemotherapy. HER2 status was not assessed in them. Iovance plans to start a frontline trial, OPTILISM, in 2027.

Lifileucel is the active ingredient in Amtagvi, which is approved for advanced melanoma. It remains investigational for lung cancer.

Iovance is scheduled to hold its third-quarter results call on November 5, with POSITILITY enrollment starting in November.

Learn

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From 8-K Items Explained: What Every Item Code From 1.01 To 9.01 Tells You, With Examples

### Sources

- [8-K Filing — IOVANCE BIOTHERAPEUTICS, INC. (IOVA)](https://www.sec.gov/Archives/edgar/data/0001425205/000110465926120261/tm2628468d1%5F8k.htm?ref=bullished.co) — SEC EDGAR
- [Exhibit tm2628468d1\_ex99-1.htm — IOVANCE BIOTHERAPEUTICS, INC. 8-K exhibit](https://www.sec.gov/Archives/edgar/data/0001425205/000110465926120261/tm2628468d1%5Fex99-1.htm?ref=bullished.co) — SEC EDGAR
- [Iovance, A Top 1% Biotech Stock, Crashes In A Surprise Lung Cancer Twist | Investor's Business Daily](https://www.investors.com/news/technology/iovance-stock-lung-cancer-treatment/?ref=bullished.co) — investors.com
- [Iovance plummets on new phase 2 Amtagvi data for non-small-cell lung cancer | Seeking Alpha](https://seekingalpha.com/news/4660656-iovance-plummets-new-phase-2-amtagvi-data-non-small-cell-lung-cancer?ref=bullished.co) — seekingalpha.com
- [Why Did IOVA Stock Jump Over 10% After-Hours Today?](https://finance.yahoo.com/markets/stocks/articles/why-did-iova-stock-jump-005722220.html?ref=bullished.co) — Yahoo Finance
- [Iovance Reports Updated IOV-LUN-202 Results and Adds Precision TIL Strategy for Second-Line Metastatic Non-Small-Cell Lung Cancer (mNSCLC)](https://finance.yahoo.com/healthcare/articles/iovance-reports-updated-iov-lun-110000935.html?.tsrc=rss&ref=bullished.co) — Yahoo Finance
- [Melanoma Trial Results Could Be A Game Changer For Iovance Biotherapeutics (IOVA)](https://finance.yahoo.com/healthcare/articles/melanoma-trial-results-could-game-220805794.html?.tsrc=rss&ref=bullished.co) — Yahoo Finance

### More on Iovance Biotherapeutics

- [Iovance's October Investor Deck Repeats Its Raised 2026 Revenue Target Of $410 Million–$420 Million](https://www.bullished.co/iovance-lifts-2026-revenue-target-to-410-million-420-million-in-october-investor-deck-4d79c13a/)
- [Iovance Raises Full-Year Revenue Guidance By $55 Million, Citing Record Amtagvi Demand](https://www.bullished.co/iovance-raises-full-year-revenue-guidance-by-55-million-citing-record-amtagvi-demand-bfd63f8d/)

[All Iovance Biotherapeutics (IOVA) coverage →](https://www.bullished.co/tag/iova/)