Correction

This article refers to:

Matching-adjusted indirect comparison of efficacy outcomes for ciltacabtagene autoleucel in CARTITUDE-1 versus idecabtagene vicleucel in KarMMa for the treatment of patients with relapsed or refractory multiple myeloma

Article title: Matching-adjusted indirect comparison of efficacy outcomes for ciltacabtagene autoleucel in CARTITUDE-1 versus idecabtagene vicleucel in KarMMa for the treatment of patients with relapsed or refractory multiple myeloma

Authors: Tom Martin, Saad Z. Usmani, Jordan M. Schecter, Martin Vogel, Carolyn C. Jackson, William Deraedt, Hong Tian, Tzu-min Yeh, Arnob Banerjee, Lida Pacaud, Ashraf Garrett, Anja Haltner, Chris Cameron, Suzy Van Sanden, Joris Diels, Satish Valluri and Imtiaz A. Samjoo

Journal: Current Medical Research and Opinion

Bibliometrics: Volume 37, Number 10, pages 1779–1788

DOI: https://doi.org/10.1080/03007995.2021.1953456

The baseline characteristic “presence of all plasmacytomas” (reported in Table 1) was incorrectly calculated for KarMMa. The current value, 32% (reported in Table 1), should be correctly reported as 40%. “Presence of all plasmacytomas” was one of the four factors included in the base case analysis. Given the error affected the base case analysis, it propagated throughout the manuscript, impacting the values reported in text, tables, figures, and supplemental material. The correction did not appreciably impact any of the reported point estimates and the statistical significance of all base case results was unchanged. However, the correction did have an impact on the DoR sensitivity analysis (all variables adjusted comparison), in which the results shifted from a significant finding to a non-significant finding. Overall, the findings of the manuscript remain valid and robust, and the overall conclusions of the manuscript remain unchanged.

Table 1. Differences in Baseline Characteristics

			Categories	Unadjusted Comparison		Base Case Adjusted^a Comparison	All Variables Adjusted^b Comparison (Sensitivity)
				KarMMa % N = 124	CARTITUDE-1 % N = 97	CARTITUDE-1 % N (ESS)=96 (59)	CARTITUDE-1 % N (ESS)=96 (48)
All Variables	Base Case Variables	Refractory status	Non triple-class refractory	16	12	16	16
			Triple or quad refractory only^c	58	45	58	58
			Penta-refractory^d	26	42	26	26
		Cytogenetic profile	High-risk^e	36	24	36	36
			Standard risk/unknown	64	76	64	64
		R-ISS stage	I	12^f	34^g	12	12
			II	71^f	59^g	71	71
			III	17^f	7^g	17	17
		Presence of all plasmacytomas	No	68	80	68	68
			Yes	32^h	20	32	32
		Number of prior LOTs	Median	6	6	5	6
		Years since MM diagnosis	Median	7	6	6	7
		Age (years)	Median	61	61	62	61
		Prior stem cell transplant	No	6^i	10	9	6
			Yes	94^i	90	91	94
		ECOG status	0	44	40	33	44
			1	56	60	67	56
		Sex	Female	42	41	41	42
			Male	58	59	59	58

^aPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, R-ISS stage, and all plasmacytomas in the base case analysis.

^bPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, R-ISS stage, all plasmacytomas, number of prior LOTs, years since MM diagnosis, age, prior stem cell transplant, ECOG status, and sex in the sensitivity analysis.

^cRefractory to two IMiDs and one PI; or two PIs and one IMiD; or two IMiDs and two PIs.

^dRefractory to at least two IMiDs, two PIs, and an anti-CD38 MoAB.

^eHigh-risk defined as at least one of del17p, t(4;14), or t(14;16).

^fPercentages are out of 121 (3 patients from KarMMa with missing R-ISS were excluded).

^gIn CARTITUDE-1, R-ISS was derived, rather than prospectively collected.

^hDefined as “paraskeletal soft-tissue masses, soft-tissue masses spreading outside the bone marrow, or both”.

ⁱAutologous stem cell transplant.

Abbreviations: ECOG, Eastern Cooperative Oncology Group; ESS, effective sample size; IMiD, immunomodulatory drug; LOTs, lines of therapy; MM, multiple myeloma; MoAB, monoclonal antibody; PI, proteasome inhibitor; R-ISS, revised International Staging System

Source: The baseline characteristics for CARTITUDE-1 were derived using individual patient data from the February 2021 data cut. KarMMa baseline patient characteristics from 2021 NEJM publication by Munshi et al [2].

Table 1. Differences in Baseline Characteristics

			Categories	Unadjusted Comparison		Base Case Adjusted^a Comparison	All Variables Adjusted^b Comparison (Sensitivity)
				KarMMa % N = 124	CARTITUDE-1 % N = 97	CARTITUDE-1 % N (ESS)=96 (52)	CARTITUDE-1 % N (ESS)=96 (42)
All Variables	Base Case Variables	Refractory status	Non triple-class refractory	16	12	16	16
			Triple or quad refractory only^c	58	45	58	58
			Penta-refractory^d	26	42	26	26
		Cytogenetic profile	High-risk^e	36	24	36	36
			Standard risk/unknown	64	76	64	64
		R-ISS stage	I	12^f	34^g	12	12
			II	71^f	59^g	71	71
			III	17^f	7^g	17	17
		Presence of all plasmacytomas	No	60	80	60	60
			Yes	40^h	20	40	40
		Number of prior LOTs	Median	6	6	5	6
		Years since MM diagnosis	Median	7	6	6	7
		Age (years)	Median	61	61	62	61
		Prior stem cell transplant	No	6^i	10	8	6
			Yes	94^i	90	92	94
		ECOG status	0	44	40	33	44
			1	56	60	67	56
		Sex	Female	42	41	42	42
			Male	58	59	58	58

^aPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, R-ISS stage, and all plasmacytomas in the base case analysis.

^bPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, R-ISS stage, all plasmacytomas, number of prior LOTs, years since MM diagnosis, age, prior stem cell transplant, ECOG status, and sex in the sensitivity analysis.

^cRefractory to two IMiDs and one PI; or two PIs and one IMiD; or two IMiDs and two PIs.

^dRefractory to at least two IMiDs, two PIs, and an anti-CD38 MoAB.

^eHigh-risk defined as at least one of del17p, t(4;14), or t(14;16).

^fPercentages are out of 121 (3 patients from KarMMa with missing R-ISS were excluded).

^gIn CARTITUDE-1, R-ISS was derived, rather than prospectively collected.

^hDefined as “paraskeletal soft-tissue masses, soft-tissue masses spreading outside the bone marrow, or both”.

ⁱAutologous stem cell transplant.

Abbreviations: ECOG, Eastern Cooperative Oncology Group; ESS, effective sample size; IMiD, immunomodulatory drug; LOTs, lines of therapy; MM, multiple myeloma; MoAB, monoclonal antibody; PI, proteasome inhibitor; R-ISS, revised International Staging System

Source: The baseline characteristics for CARTITUDE-1 were derived using individual patient data from the February 2021 data cut. KarMMa baseline patient characteristics from 2021 NEJM publication by Munshi et al [2].

The correction is outlined below:

Page 1, Abstract, Paragraph 3 (Results), Lines 1–6:

Original text: Cilta-cel was associated with statistically significantly improved ORR (odds ratio [OR]: 87.99 [95% confidence interval [CI]: 20.32, 381.01; p<.0001]; relative risk [RR]: 1.34), ≥CR rate (OR: 5.96 [95% CI: 2.76, 12.88; p<.0001]; RR: 2.26), DoR (hazard ratio [HR]: 0.48 [95% CI: 0.28, 0.81; p=.0058]), and PFS (HR: 0.36 [95% CI: 0.22, 0.59; p<.0001]) when compared with ide-cel. For OS, the results were in favor of cilta-cel and clinically meaningful but with a CI overlapping one (HR: 0.54 [95% CI: 0.29, 1.01; p=.0527]).

Revised text: Cilta-cel was associated with statistically significantly improved ORR (odds ratio [OR]: 94.93 [95% confidence interval [CI]: 21.86, 412.25; p<.0001]; relative risk [RR]: 1.34), ≥CR rate (OR: 5.49 [95% CI: 2.47, 12.21; p<.0001]; RR: 2.21), DoR (hazard ratio [HR]: 0.50 [95% CI: 0.29, 0.87; p=.0137]), and PFS (HR: 0.37 [95% CI: 0.22, 0.62; p=.0002]) when compared with ide-cel. For OS, the results were in favor of cilta-cel and clinically meaningful but with a CI overlapping one (HR: 0.55 [95% CI: 0.29, 1.05; p=.0702]).

Page 3, Paragraph 7 (Results, Population alignment), Lines 20–27:

Original text: In the comparison that adjusted for the base case variables, the means of the adjusted covariates aligned exactly across the two populations, accompanied by a 39% reduction in ESS for the cilta-cel treated population. Furthermore, the sensitivity analysis which adjusted for all variables improved the overall population alignment compared to the base case; however, it reduced the ESS by 50% for the cilta-cel treated population.

Revised text: In the comparison that adjusted for the base case variables, the means of the adjusted covariates aligned exactly across the two populations, accompanied by a 46% reduction in ESS for the cilta-cel treated population. Furthermore, the sensitivity analysis which adjusted for all variables improved the overall population alignment compared to the base case; however, it reduced the ESS by 57% for the cilta-cel treated population.

Page 3, Paragraph 9 (Results, Overall response and ≥ complete response rate), Lines 4–8:

Original text: After base case adjustment, patients treated with cilta-cel were 1.3-fold more likely to respond (OR: 87.99 [95% CI: 20.32, 381.01; p<.0001]; RR: 1.34) and 2.3-fold more likely to achieve ≥ CR (OR: 5.96 [95% CI: 2.76, 12.88; p<.0001]; RR: 2.26) compared to patients treated with ide-cel.

Revised text: After base case adjustment, patients treated with cilta-cel were 1.3-fold more likely to respond (OR: 94.93 [95% CI: 21.86, 412.25; p<.0001]; RR: 1.34) and 2.2-fold more likely to achieve ≥ CR (OR: 5.49 [95% CI: 2.47, 12.21; p<.0001]; RR: 2.21) compared to patients treated with ide-cel.

Page 4, Paragraph 2 (Results, Duration of response), Lines 2–5:

Original text: The effect of cilta-cel was statistically significantly superior to ide-cel after base case adjustment (HR: 0.48 [95% CI: 0.28, 0.81; p=.0058]).

Revised text: The effect of cilta-cel was statistically significantly superior to ide-cel after base case adjustment (HR: 0.50 [95% CI: 0.29, 0.87); p=.0137]).

Page 4, Paragraph 3 (Results, Duration of response), Lines 1–4:

Original text: The Grambsch-Therneau test [1] for violation of the proportional hazards assumption was non-significant for the base case adjusted analysis (p=.11), indicating that the proportional hazards assumption was not violated.

Revised text: The Grambsch-Therneau test [1] for violation of the proportional hazards assumption was non-significant for the base case adjusted analysis (p=.12), indicating that the proportional hazards assumption was not violated.

Page 4, Paragraph 5 (Results, Progression-free survival and overall survival), Lines 3–8:

Original text: The effect of cilta-cel for PFS was statistically significantly superior to ide-cel after base case adjustment (HR: 0.36 [95% CI: 0.22, 0.59; p<.0001]). For OS, the estimated treatment effect was in favor of cilta-cel (HR: 0.54 [95% CI: 0.29, 1.01; p=.0527]), but with widened CIs overlapping one.

Revised text: The effect of cilta-cel for PFS was statistically significantly superior to ide-cel after base case adjustment (HR: 0.37 [95% CI: 0.22, 0.62; p=.0002]). For OS, the estimated treatment effect was in favor of cilta-cel (HR: 0.55 [95% CI: 0.29, 1.05; p=.0702]), but with widened CIs overlapping one.

Page 4, Paragraph 6 (Results, Progression-free survival and overall survival), Lines 1–5:

Original text: The Grambsch-Therneau test [1] for violation of the proportional hazards assumption was non-significant for both outcomes in the base case adjusted analysis (PFS: p=.60; OS: p=.17), indicating that the proportional hazard assumption was not violated.

Revised text: The Grambsch-Therneau test [1] for violation of the proportional hazards assumption was non-significant for both outcomes in the base case adjusted analysis (PFS: p=.62; OS: p=.19), indicating that the proportional hazard assumption was not violated.

Page 5, Paragraph 1 (Results, Sensitivity analyses), Lines 5–10:

Original text: Comparative efficacy estimates for the all variables adjusted comparison were as follows: ORR: OR = 66.10 (95% CI: 11.72, 372.92; p<.0001); RR = 1.34; ≥CR rate: OR = 4.65 (95% CI: 2.12, 10.18; p=.0001); RR = 2.11; DoR: HR = 0.55 (95% CI: 0.32, 0.93; p=.0262); PFS: HR = 0.41 (95% CI: 0.25, 0.67; p=.0004); and OS: HR = 0.59 (95% CI: 0.30, 1.14; p=.1162).

Revised text: Comparative efficacy estimates for the all variables adjusted comparison were as follows: ORR: OR = 70.53 (95% CI: 12.23, 406.82; p<.0001); RR = 1.34; ≥CR rate: OR = 4.18 (95% CI: 1.86, 9.43; p=.0006); RR = 2.04; DoR: HR = 0.58 (95% CI: 0.33, 1.02; p=.0600); PFS: HR = 0.43 (95% CI: 0.25, 0.73; p=.0016); and OS: HR = 0.62 (95% CI: 0.31, 1.23; p=.1680). For DoR, the results were in favor of cilta-cel but with a CI overlapping one.

Page 5, Paragraph 3 (Discussion), Lines 16–21:

Original text: Patients treated with cilta-cel were 1.3-fold more likely to respond and 2.3-fold more likely to achieve a ≥ CR when compared with ide-cel, demonstrating a higher likelihood of a deeper response with cilta-cel. Furthermore, cilta-cel reduced the risk of disease progression or death by approximately 52% in responders and 64% in all patients.

Revised text: Patients treated with cilta-cel were 1.3-fold more likely to respond and 2.2-fold more likely to achieve a ≥ CR when compared with ide-cel, demonstrating a higher likelihood of a deeper response with cilta-cel. Furthermore, cilta-cel reduced the risk of disease progression or death by approximately 50% in responders and 63% in all patients.

Page 6, Paragraph 1 (Discussion), Lines 1–4:

Original text: analyses adjusting for additional prognostic factors showed consistent statistically significant estimates for ORR, ≥CR rate, DoR, and PFS in favor of cilta-cel, showing robustnessof findings from the base case analysis.

Revised text: analyses adjusting for additional prognostic factors showed consistent statistically significant estimates for ORR, ≥CR rate, and PFS in favor of cilta-cel, showing robustnessof findings from the base case analysis. For the sensitivity analysis with DoR, the results were in favor of cilta-cel and clinically meaningful but with a CI overlapping one.

Page 6, Paragraph 2 (Discussion), Lines 4–7:

Original text: In the base case adjusted comparison, cilta-cel showed a reduction in the risk of death by approximately 46% compared to ide-cel; however, a limited number of events resulted in low power for the OS outcome.

Revised text: In the base case adjusted comparison, cilta-cel showed a reduction in the risk of death by approximately 45% compared to ide-cel; however, a limited number of events resulted in low power for the OS outcome.

Page 8, Paragraph 2 (Conclusion), Lines 1–3:

Original text: Cilta-cel demonstrated clinically superior results for all outcomes studied (ORR, ≥CR rate, DoR, PFS, and OS), and these were robust across all sensitivity analyses.

Revised text: Cilta-cel demonstrated clinically superior results for all outcomes studied (ORR, ≥CR rate, DoR, PFS, and OS), and these were robust across sensitivity analyses.

Page 4, Table 1:

Original table:

Revised table:

Page 5, Table 2:

Table 2. Response Rates and Comparative Efficacy for Cilta-cel versus Ide-cel

	Unadjusted Comparison			Base Case Adjusted^a Comparison			All Variables Adjusted^b Comparison (Sensitivity)
	Observed Response Rate		OR^c (95%CI), p-value	Adjusted Response Rate	OR^c (95%CI), p-value	Relative Risk^d	Adjusted Response Rate	OR^c (95%CI), p-value	Relative Risk^d
	Cilta-cel	Ide-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel vs Ide-cel
Overall Response Rate	97.9%	74.2%	16.52 (3.85, 70.93), p=.0002	99.6%	87.99 (20.32, 381.01), p<.0001	1.34	99.5%	66.10 (11.72, 372.92), p<.0001	1.34
Complete Response or Better Rate	80.4%	33.1%	8.31 (4.45, 15.54), p<.0001	74.7%	5.96 (2.76, 12.88), p<.0001	2.26	69.7%	4.65 (2.12, 10.18), p=.0001	2.11

^aPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas in the base case analysis.

^bPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, all plasmacytomas, number of prior lines of therapy, years since multiple myeloma diagnosis, age, prior stem cell transplant, Eastern Cooperative Oncology Group status, and sex in the sensitivity analysis.

^cOdds ratios (ORs) >1 are in favor of cilta-cel versus ide-cel.

^dRelative risks are equal to the ratio of the adjusted response rates for cilta-cel versus the observed response rates for ide-cel.

Abbreviations: CI, confidence interval; ESS, effective sample size; OR, odds ratio

Table 2. Response Rates and Comparative Efficacy for Cilta-cel versus Ide-cel

	Unadjusted Comparison			Base Case Adjusted^a Comparison			All Variables Adjusted^b Comparison (Sensitivity)
	Observed Response Rate		OR^c (95%CI), p-value	Adjusted Response Rate	OR^c (95%CI), p-value	Relative Risk^d	Adjusted Response Rate	OR^c (95%CI), p-value	Relative Risk^d
	Cilta-cel	Ide-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel vs Ide-cel
Overall Response Rate	97.9%	74.2%	16.52 (3.85, 70.93), p=.0002	99.6%	94.93 (21.86, 412.25), p<.0001	1.34	99.5%	70.53 (12.23, 406.82), p<.0001	1.34
Complete Response or Better Rate	80.4%	33.1%	8.31 (4.45, 15.54), p<.0001	73.0%	5.49 (2.47, 12.21), p<.0001	2.21	67.4%	4.18 (1.86, 9.43), p=.0006	2.04

^aPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas in the base case analysis.

^bPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, all plasmacytomas, number of prior lines of therapy, years since multiple myeloma diagnosis, age, prior stem cell transplant, Eastern Cooperative Oncology Group status, and sex in the sensitivity analysis.

^cOdds ratios (ORs) >1 are in favor of cilta-cel versus ide-cel.

^dRelative risks are equal to the ratio of the adjusted response rates for cilta-cel versus the observed response rates for ide-cel.

Abbreviations: CI, confidence interval; ESS, effective sample size; OR, odds ratio

Original table:

Revised table:

Page 6, Table 3:

Table 3. Estimated Medians and Comparative Efficacy for Cilta-cel versus Ide-cel

	Unadjusted Comparison			Base Case Adjusted^a Comparison		All Variables Adjusted^b Comparison (Sensitivity)
	Median, months (95% CI)		HR^c (95% CI), p-value	Median, months (95% CI)	HR^c (95% CI), p-value	Median, months (95% CI)	HR^c (95% CI), p-value
	Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel
Duration of Response^d	11.1 (9.1, 11.3)	21.8 (21.8, NR)^e	0.33 (0.21, 0.52), p<.0001	21.8 (14.4, NR)^e	0.48 (0.28, 0.81), p=.0058	15.9 (13.8, NR)^e	0.55 (0.32, 0.93), p=.0262
Progression-free Survival	9.2 (6.0, 12.1)	22.8 (22.8, NR)^e	0.26 (0.17, 0.40), p<.0001	22.8 (16.8, NR)^e	0.36 (0.22, 0.59), p<.0001	16.8 (14.6, NR)^e	0.41 (0.25, 0.67), p=.0004
Overall Survival^f	19.5 (18.9, NR)	NR (23.6, NR)	0.39 (0.23, 0.66), p=.0004	NR (22.8, NR)	0.54 (0.29, 1.01), p=.0527	19.5 (23.6, NR)	0.59 (0.30, 1.14), p=.1162

^aPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas in the base case analysis.

^bPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, all plasmacytomas, number of prior lines of therapy, years since multiple myeloma diagnosis, age, prior stem cell transplant, Eastern Cooperative Oncology Group status, and sex in the sensitivity analysis.

^cHazard ratios (HRs) <1 are in favor of cilta-cel.

^dFor KarMMa, estimates were calculated using the number of responders (N = 92).

^eMedians should be interpreted with caution, as reached when few patients were still at risk and may be an underestimate.

^fFor KarMMa, estimates were calculated using publicly available data, which excluded one patient who received a non-confirming product that did not meet product release specifications for ide-cel (N = 123).

Abbreviations: CI, confidence interval; HR, hazard ratio; NR, not reached

Table 3. Estimated Medians and Comparative Efficacy for Cilta-cel versus Ide-cel

	Unadjusted Comparison			Base Case Adjusted^a Comparison		All Variables Adjusted^b Comparison (Sensitivity)
	Median, months (95% CI)		HR^c (95% CI), p-value	Median, months (95% CI)	HR^c (95% CI), p-value	Median, months (95% CI)	HR^c (95% CI), p-value
	Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel	Cilta-cel	Cilta-cel vs Ide-cel
Duration of Response^d	11.1 (9.1, 11.3)	21.8 (21.8, NR)^e	0.33 (0.21, 0.52), p<.0001	21.8 (12.9, NR)^e	0.50 (0.29, 0.87), p=.0137	15.9 (12.9, NR)^e	0.58 (0.33, 1.02), p=.0600
Progression-free Survival	9.2 (6.0, 12.1)	22.8 (22.8, NR)^e	0.26 (0.17, 0.40), p<.0001	22.8 (14.6, NR)^e	0.37 (0.22, 0.62), p=.0002	16.8 (1.0, NR)^e	0.43 (0.25, 0.73), p=.0016
Overall Survival^f	19.5 (18.9, NR)	NR (23.6, NR)	0.39 (0.23, 0.66), p=.0004	NR (22.8, NR)	0.55 (0.29, 1.05), p=.0702	NR (22.8, NR)	0.62 (0.31, 1.23), p=.1680

^aPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas in the base case analysis.

^bPatients from CARTITUDE-1 who satisfied KarMMa’s eligibility criteria were adjusted for refractory status, cytogenetic profile, revised International Staging System stage, all plasmacytomas, number of prior lines of therapy, years since multiple myeloma diagnosis, age, prior stem cell transplant, Eastern Cooperative Oncology Group status, and sex in the sensitivity analysis.

^cHazard ratios (HRs) <1 are in favor of cilta-cel.

^dFor KarMMa, estimates were calculated using the number of responders (N = 92).

^eMedians should be interpreted with caution, as reached when few patients were still at risk and may be an underestimate.

^fFor KarMMa, estimates were calculated using publicly available data, which excluded one patient who received a non-confirming product that did not meet product release specifications for ide-cel (N = 123).

Abbreviations: CI, confidence interval; HR, hazard ratio; NR, not reached

Original table:

Revised table:

Page 7, Figure 1:

Figure 1. Observed (unadjusted) and adjusted (base case) Kaplan–Meier plots of a duration of response. Note. Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas. Abbreviations: ESS, effective sample size.

Figure 1. Observed (unadjusted) and adjusted (base case) Kaplan–Meier plots of a duration of response. Note. Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas. Abbreviations: ESS, effective sample size.

Original figure:

Revised figure:

Page 7, Figure 2:

Original figure:

Figure 2. Observed (unadjusted) and adjusted (base case) Kaplan–Meier plots of progression-free survival. Note. Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas. Abbreviations: ESS, effective sample size.

Revised figure:

Figure 2. Observed (unadjusted) and adjusted (base case) Kaplan–Meier plots of progression-free survival. Note. Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas. Abbreviations: ESS, effective sample size.

Page 8, Figure 3:

Original figure:

Figure 3. Observed (unadjusted) and adjusted (base case) Kaplan–Meier plots of overall survival. Note. Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas. Abbreviations: ESS, effective sample size.

Revised figure:

Figure 3. Observed (unadjusted) and adjusted (base case) Kaplan–Meier plots of overall survival. Note. Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas. Abbreviations: ESS, effective sample size.

Supplemental Appendix, Page 5, Figure D.1:

Original figure:

Note: Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas.

Abbreviations: MAIC, matching-adjusted indirect comparison

Revised figure:

Note: Base case results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, and all plasmacytomas.

Abbreviations: MAIC, matching-adjusted indirect comparison

Supplemental Appendix, Page 6, Figure D.2:

Original figure:

Note: Sensitivity Analysis results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, all plasmacytomas, number of prior lines of therapy, years since multiple myeloma diagnosis, age, prior stem cell transplant, Eastern Cooperative Oncology Group status, and sex.

Abbreviations: MAIC, matching-adjusted indirect comparison

Revised figure:

Note: Sensitivity Analysis results adjusted for refractory status, cytogenetic profile, revised International Staging System stage, all plasmacytomas, number of prior lines of therapy, years since multiple myeloma diagnosis, age, prior stem cell transplant, Eastern Cooperative Oncology Group status, and sex.

Abbreviations: MAIC, matching-adjusted indirect comparison

Supplemental Appendix, Page 7, Table E.1:

Table E.1: Detailed Sensitivity Analysis Results for Overall Response Rate, Complete Response or Better Rate, Duration of Response, Progression-free Survival, and Overall Survival

	N (ESS)^a CARTITUDE-1	N^a KarMMa	Overall Response Rate OR^b (95% CI), p-value	Complete Response or Better Rate OR^b (95% CI), p-value	Duration of Response HR^b (95% CI), p-value	Progression-free Survival HR^b (95% CI), p-value	Overall Survival HR^b (95% CI), p-value
Unadjusted Comparison
	97	124	16.52 (3.85, 70.93),	8.31 (4.45, 15.54),	0.33 (0.21, 0.52),	0.26 (0.17, 0.40),	0.39 (0.23, 0.66),
			p=.0002	p<.0001	p<.0001	p<.0001	p=.0004
Adjusted Comparisons
+ Refractory status + Cytogenetic risk + R-ISS Stage ^c + All plasmacytomas	96 (59)	124	87.99 (20.32, 381.01),	5.96 (2.76, 12.88),	0.48 (0.28, 0.81),	0.36 (0.22, 0.59),	0.54 (0.29, 1.01),
			p<.0001	p<.0001	p=.0058	p<.0001	p=.0527
+Number of prior LOTs	96 (51)	124	91.47 (18.68, 447.98),	5.43 (2.45, 12.02),	0.50 (0.29, 0.86),	0.37 (0.23, 0.62),	0.57 (0.30, 1.11),
			p<.0001	p<.0001	p=.0115	p=.0002	p=.0981
+ Years since MM diagnosis	96 (51)	124	89.80 (18.16, 444.13),	5.32 (2.40, 11.80),	0.50 (0.29, 0.87),	0.38 (0.23, 0.63),	0.58 (0.30, 1.12),
			p<.0001	p<.0001	p=.0129	p=.0002	p=.1038
+Age	96 (50)	124	84.57 (15.09, 474.04),	5.12 (2.33, 11.26),	0.52 (0.30, 0.88),	0.39 (0.23, 0.64),	0.57 (0.30, 1.10),
			p<.0001	p<.0001	p=.0155	p=.0002	p=.0960
+Stem cell transplant	96 (49)	124	79.91 (14.34, 445.51),	5.30 (2.40, 11.71),	0.51 (0.30, 0.88),	0.39 (0.23, 0.64),	0.58 (0.30, 1.12),
			p<.0001	p<.0001	p=.0150	p=.0002	p=.1022
+ECOG Status	96 (48)	124	67.46 (11.97, 380.25),	4.68 (2.14, 10.24),	0.54 (0.32, 0.93),	0.41 (0.25, 0.67),	0.58 (0.30, 1.13),
			p<.0001	p=.0001	p=.0254	p=.0004	p=.1109
+Sex	96 (48)	124	66.097 (11.72, 372.92),	4.65 (2.12, 10.18),	0.55 (0.32, 0.93),	0.41 (0.25, 0.67),	0.59 (0.30, 1.14),
			p<.0001	p=.0001	p=.0262	p=.0004	p=.1162

Note: The ‘+’ denotes cumulative inclusion of the factor. The base case adjusted for refractory status, cytogenetic profile, R-ISS stage, and all plasmacytomas.

^aSample size reflects overall study population used in matching and adjusting and is not specific to patients for whom duration of response and overall survival were assessed.

^bOdds ratios (ORs) >1 and hazard ratios (HRs) <1 are in favor of cilta-cel versus ide-cel.

^cIn CARTITUDE-1, R-ISS was derived, rather than prospectively collected.

Abbreviations: CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; ESS, effective sample size; HR, hazard ratio; LOTs, lines of therapy; MM, multiple myeloma; OR, odds ratio; R-ISS, revised International Staging System

Table E.1: Detailed Sensitivity Analysis Results for Overall Response Rate, Complete Response or Better Rate, Duration of Response, Progression-free Survival, and Overall Survival

	N (ESS)^a CARTITUDE-1	N^a KarMMa	Overall Response Rate OR^b (95% CI), p-value	Complete Response or Better Rate OR^b (95% CI), p-value	Duration of Response HR^b (95% CI), p-value	Progression-free Survival HR^b (95% CI), p-value	Overall Survival HR^b (95% CI), p-value
Unadjusted Comparison
	97	124	16.52 (3.85, 70.93),	8.31 (4.45, 15.54),	0.33 (0.21, 0.52),	0.26 (0.17, 0.40),	0.39 (0.23, 0.66),
			p=.0002	p<.0001	p<.0001	p<.0001	p=.0004
Adjusted Comparisons
+ Refractory status + Cytogenetic risk + R-ISS Stage^c + All plasmacytomas	96 (52)	124	94.93 (21.86, 412.25),	5.49 (2.47, 12.21),	0.50 (0.29, 0.87),	0.37 (0.22, 0.62),	0.55 (0.29, 1.05),
			p<.0001	p<.0001	p=.0137	p=.0002	p=.0702
+Number of prior LOTs	96 (45)	124	100.88 (20.06, 507.37),	5.07 (2.24, 11.47),	0.52 (0.29, 0.91),	0.39 (0.23, 0.66),	0.59 (0.30, 1.16),
			p<.0001	p=.0001	p=.0232	p=.0005	p=.1261
+ Years since MM diagnosis	96 (45)	124	98.04 (19.19, 500.77),	4.92 (2.17, 11.16),	0.53 (0.30, 0.93),	0.39 (0.23, 0.67),	0.59 (0.30, 1.18),
			p<.0001	p=.0001	p=.0273	p=.0006	p=.1363
+Age	96 (44)	124	90.91 (15.94, 518.65),	4.76 (2.11, 10.74),	0.54 (0.31, 0.95),	0.40 (0.24, 0.68),	0.59 (0.30, 1.16),
			p<.0001	p=.0002	p=.0332	p=.0007	p=.1262
+Stem cell transplant	96 (44)	124	86.44 (15.23, 490.53),	4.86 (2.13, 11.08),	0.54 (0.31, 0.95),	0.40 (0.24, 0.68),	0.59 (0.30, 1.18),
			p<.0001	p=.0002	p=.0334	p=.0008	p=.1342
+ECOG Status	96 (42)	124	73.55 (12.78, 423.20),	4.24 (1.88, 9.57),	0.58 (0.33, 1.02),	0.42 (0.25, 0.72),	0.60 (0.30, 1.20),
			p<.0001	p=.0005	p=.0564	p=.0015	p=.1514
+Sex	96 (42)	124	70.53 (12.23, 406.82),	4.18 (1.86, 9.43),	0.58 (0.33, 1.02),	0.43 (0.25, 0.73),	0.62 (0.31, 1.23),
			p<.0001	p=.0006	p=.0600	p=.0016	p=.1680

Note: The ‘+’ denotes cumulative inclusion of the factor. The base case adjusted for refractory status, cytogenetic profile, R-ISS stage, and all plasmacytomas.

^aSample size reflects overall study population used in matching and adjusting and is not specific to patients for whom duration of response and overall survival were assessed.

^bOdds ratios (ORs) >1 and hazard ratios (HRs) <1 are in favor of cilta-cel versus ide-cel.

^cIn CARTITUDE-1, R-ISS was derived, rather than prospectively collected.

Abbreviations: CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; ESS, effective sample size; HR, hazard ratio; LOTs, lines of therapy; MM, multiple myeloma; OR, odds ratio; R-ISS, revised International Staging System

Original table:

Revised table:

References cited in this correction

1. Grambsch PM, Therneau TM. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika. 1994;81(3):515–526.

2. Munshi NC, Anderson LD, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. 2021;384(8):705–716.